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Data / Medical devices / Screw, Fixation, Bone / United States

FDA-registered makers of Screw, Fixation, Bone in the United States: 301 establishments

301 establishments in the United States are registered with the FDA to make Screw, Fixation, Bone (product code HWC). 110 have a 510(k) clearance or PMA approval on file and 33 have a recall event. FDA data exported November 2, 2026.

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Device
Screw, Fixation, Bone
Product code
HWC
Country
United States

Makers of Screw, Fixation, Bone in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Biomet, Inc.Warsaw, IN, United StatesContract manufacturer, Manufacturer, Repackager or relabeler48February 24, 20200140api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesComplaint file establishment, Specification developer46February 17, 2023010api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesComplaint file establishment, Specification developer45November 26, 2019050api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesManufacturer, Manufacturer for export39February 17, 2023020api.fda.gov
Arthrex, Inc.Naples, FL, United StatesManufacturer, Specification developer35September 25, 2026010api.fda.gov
DePuy Mitek, Inc.Raynham, MA, United StatesSpecification developer31February 1, 2013020api.fda.gov
Smith & Nephew Inc.Mansfield, MA, United StatesManufacturer, Specification developer25May 13, 2014010api.fda.gov
Acumed LLCHillsboro, OR, United StatesManufacturer, Specification developer19June 9, 2023070api.fda.gov
Linvatec CorporationLargo, FL, United StatesManufacturer, Specification developer18January 22, 2019000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer18July 14, 2017030api.fda.gov
OsteomedAddison, TX, United StatesComplaint file establishment, Manufacturer, Specification developer14October 15, 2020000api.fda.gov
Smith & Nephew Inc.Andover, MA, United StatesSpecification developer13May 13, 2014030api.fda.gov
OsteoCentric Technologies,IncLogan, UT, United StatesComplaint file establishment, Specification developer12October 2, 2026000api.fda.gov
Zimmer, Inc.Warsaw, IN, United StatesContract manufacturer, Manufacturer12November 24, 2015090api.fda.gov
Vilex LLCMcminnville, TN, United StatesManufacturer11March 5, 2025000api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesComplaint file establishment, Manufacturer, Specification developer9September 17, 2007050api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer9May 15, 2014000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer9May 15, 2014000api.fda.gov
Eagle Medical Packaging Sterilization, Inc.Paso Robles, CA, United StatesContract manufacturer, Repackager or relabeler8April 27, 2022000api.fda.gov
Extremity Medical, LLCParsippany, NJ, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer8October 8, 2025020api.fda.gov
Trimed, Inc.Santa Clarita, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer8August 12, 2026010api.fda.gov
Arthrex Manufacturing Inc.Pendleton, SC, United StatesContract manufacturer, Contract sterilizer, Manufacturer7March 26, 2019000api.fda.gov
Nvision Biomedical Technologies, IncSan Antonio, TX, United StatesRepackager or relabeler, Specification developer7February 5, 2025000api.fda.gov
Paragon 28Englewood, CO, United StatesComplaint file establishment, Manufacturer, Specification developer7October 12, 2023000api.fda.gov
Crossroads Extremity Systems LLCMemphis, TN, United StatesComplaint file establishment, Manufacturer6August 19, 2019010api.fda.gov
Life SpineHuntley, IL, United StatesSpecification developer6December 14, 2017000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer6August 2, 2024000api.fda.gov
Smith & Nephew Inc.Oklahoma City, OK, United StatesManufacturer, Repackager or relabeler6May 15, 2014000api.fda.gov
Treace Medical Concepts, Inc.Ponte Vedra, FL, United StatesManufacturer6March 6, 2026000api.fda.gov
Tyber MedicalBethlehem, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer6January 9, 2020000api.fda.gov
Biomet MicrofixationJacksonville, FL, United StatesManufacturer, Repackager or relabeler, Specification developer5May 26, 2015020api.fda.gov
Depuy Orthopaedics, Inc.Warsaw, IN, United StatesManufacturer, Specification developer5July 9, 1997000api.fda.gov
Fusion Orthopedics Usa, LLCMesa, AZ, United StatesComplaint file establishment, Specification developer5May 21, 2019000api.fda.gov
Medshape, Inc.Atlanta, GA, United StatesComplaint file establishment, Manufacturer, Specification developer5September 23, 2026010api.fda.gov
Microaire Surgical Instruments LLCCharlottesville, VA, United StatesManufacturer5June 12, 2006010api.fda.gov
Parcus Medical, L.L.C.Sarasota, FL, United StatesManufacturer5July 28, 2011000api.fda.gov
TORNIER Inc.Columbia City, IN, United StatesSpecification developer5May 31, 2013000api.fda.gov
Tornier, Inc.Bloomington, MN, United StatesComplaint file establishment, Manufacturer, Manufacturer for export5May 31, 2013030api.fda.gov
Trilliant Surgical LLCHouston, TX, United StatesContract manufacturer, Manufacturer5October 26, 2018060api.fda.gov
Tyber MedicalBethlehem, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer5January 9, 2020000api.fda.gov
Arthrosurface, Inc.W Bridgewater, MA, United StatesManufacturer4December 22, 2017000api.fda.gov
Biopro, Inc.Port Huron, MI, United StatesContract manufacturer, Manufacturer4June 3, 2010000api.fda.gov
CovidienNorth Haven, CT, United StatesManufacturer4October 20, 2004000api.fda.gov
FLOWER ORTHOPEDICS CORPORATION DBA Conventus FlowerHorsham, PA, United StatesComplaint file establishment, Specification developer4November 22, 2024010api.fda.gov
Medartis Inc.Warsaw, IN, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer4November 6, 2020060api.fda.gov
Orthofix Us LLCLewisville, TX, United StatesRepackager or relabeler, Specification developer4January 18, 2022000api.fda.gov
RTI Surgical, Inc. (dba RTI Biologics, Inc.)Alachua, FL, United StatesManufacturer4May 9, 2007000api.fda.gov
Skeletal Dynamics, IncMiami, FL, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer4April 28, 2023000api.fda.gov
Zimmer Manufacturing B.V.Mercedita, PR, United StatesContract manufacturer, Manufacturer4November 24, 2015030api.fda.gov
Arthrex Logistic CenterFort Myers, FL, United StatesManufacturer3May 11, 2017000api.fda.gov
Cayenne Medical, Inc.Scottsdale, AZ, United StatesManufacturer3March 4, 2009010api.fda.gov
Depuy Spine, Inc.Raynham, MA, United StatesSpecification developer3November 14, 1996010api.fda.gov
Encore Medical, L.P.Austin, TX, United StatesManufacturer3March 12, 1998020api.fda.gov
Exactech, Inc.Gainesville, FL, United StatesManufacturer3February 28, 2017000api.fda.gov
Globus Medical, Inc.Audubon, PA, United StatesManufacturer3September 8, 2022000api.fda.gov
Gramercy Extremity Orthopedics, LLC.Richardson, TX, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer3October 22, 2020000api.fda.gov
In2bones Usa, LLCCordova, TN, United StatesManufacturer, Repackager or relabeler, Specification developer3May 30, 2026020api.fda.gov
Stryker Puerto Rico, LLC.Arroyo, PR, United StatesContract manufacturer, Manufacturer3September 17, 2007000api.fda.gov
ArthroCare CorporationAustin, TX, United StatesSpecification developer2October 1, 2008010api.fda.gov
Conmed CorporationUtica, NY, United StatesComplaint file establishment, Contract manufacturer, Manufacturer2May 30, 2026000api.fda.gov
Diamond OrthopedicGastonia, NC, United StatesContract manufacturer, Manufacturer, Repackager or relabeler2May 9, 2018000api.fda.gov
Dev4Houston, TX, United StatesSpecification developer2October 10, 2025000api.fda.gov
GLW, Inc.Englewood Cliffs, NJ, United StatesComplaint file establishment, Specification developer2January 25, 2023000api.fda.gov
Graham Medical Technologies, L.L.C. d.b.a. GraMedicaRochester, MI, United StatesManufacturer, Specification developer2October 3, 2014000api.fda.gov
Howmedica Osteonics CorpMahwah, NJ, United StatesManufacturer, Specification developer2September 11, 1989070api.fda.gov
Kyocera Medical Technologies, Inc.Redlands, CA, United StatesComplaint file establishment, Specification developer2December 9, 2011000api.fda.gov
Mahe Medical UsaLaramie, WY, United StatesComplaint file establishment, Specification developer2April 24, 2012000api.fda.gov
Ortho Precision ProductsHawthorne, CA, United StatesManufacturer2January 14, 2016000api.fda.gov
Orthonovis, Inc.Palm Coast, FL, United StatesManufacturer, Repackager or relabeler, Specification developer2October 2, 2025000api.fda.gov
Orthopediatrics, CorpWarsaw, IN, United StatesComplaint file establishment, Repackager or relabeler, Specification developer2July 5, 2019040api.fda.gov
Orthopedic Designs North America, Inc.Tampa, FL, United StatesManufacturer2April 13, 2022000api.fda.gov
Responsive ArthroscopyMinneapolis, MN, United StatesSpecification developer2September 23, 2020000api.fda.gov
S2ortho, LLCYardley, PA, United StatesSpecification developer2July 13, 2018000api.fda.gov
Subchondral SolutionsCosta Mesa, CA, United StatesComplaint file establishment, Specification developer2April 18, 2020000api.fda.gov
The Orthopaedic Implant CompanyReno, NV, United StatesSpecification developer2February 13, 2023000api.fda.gov
A.M. Surgical, Inc.Nashua, NH, United StatesSpecification developer1October 16, 2019000api.fda.gov
Astra Orthomed, Inc.Woodstock, GA, United StatesSpecification developer1August 27, 2025000api.fda.gov
Auxano Medical LLCBrecksville, OH, United StatesSpecification developer1September 29, 2023000api.fda.gov
Avanti Orthopaedics LLCPenn Valley, PA, United StatesComplaint file establishment, Specification developer1November 23, 2022000api.fda.gov
Culver Tool & EngineeringPlymouth, IN, United StatesContract manufacturer, Manufacturer1July 7, 2017000api.fda.gov
Curvafix, Inc.Kirkland, WA, United StatesManufacturer1August 29, 2025000api.fda.gov
Depuy Orthopaedics, Inc.Raynham, MA, United StatesManufacturer1June 9, 1997000api.fda.gov
Dunamis Medical LLCGreenville, AL, United StatesManufacturer, Specification developer1August 15, 2025000api.fda.gov
Forma Medical, Inc.Camp Hill, PA, United StatesSpecification developer1July 18, 2023000api.fda.gov
Globus Medical, Inc.Memphis, TN, United StatesManufacturer1December 9, 2011000api.fda.gov
Highridge Medical, LLCWestminster, CO, United StatesSpecification developer1November 7, 1997000api.fda.gov
Iconn Orthopedics, LLCBirmingham, AL, United StatesComplaint file establishment, Manufacturer, Specification developer1December 7, 2018000api.fda.gov
KLS-Martin L.P.Jacksonville, FL, United StatesSpecification developer1December 19, 2016000api.fda.gov
Medical Surgical, Inc.Andover, MN, United StatesSpecification developer1May 17, 1995000api.fda.gov
Medtronic Puerto Rico Operations Co., HumacaoHumacao, PR, United StatesManufacturer1September 8, 2006000api.fda.gov
Microport Orthopedics Inc.Arlington, TN, United StatesManufacturer1December 15, 1986010api.fda.gov
Medtronic NeurosurgeryFort Worth, TX, United StatesSpecification developer1September 8, 2006000api.fda.gov
Ortho Outcomes, LLCSalt Lake City, UT, United StatesSpecification developer1June 26, 2023000api.fda.gov
OrthocircleSavannah, GA, United StatesSpecification developer1January 10, 2023000api.fda.gov
Orthopedic Generations LLCMokena, IL, United StatesSpecification developer1March 23, 2015000api.fda.gov
Omnia MedicalMorgantown, WV, United StatesSpecification developer1February 27, 2020000api.fda.gov
Pace SurgicalMalvern, PA, United StatesSpecification developer1November 6, 2025000api.fda.gov
Providence Medical Technology, Inc.Pleasanton, CA, United StatesComplaint file establishment, Manufacturer, Specification developer1May 31, 2017010api.fda.gov
Relja Innovations, IncWauwatosa, WI, United StatesComplaint file establishment, Specification developer1January 31, 2022000api.fda.gov
Retrofix Screws, LLCSalisbury, NC, United StatesSpecification developer1June 26, 2020000api.fda.gov
SIGN Fracture Care InternationalRichland, WA, United StatesManufacturer1February 25, 2016000api.fda.gov
Stabiliz OrthopaedicsExton, PA, United StatesComplaint file establishment, Specification developer1April 19, 2023000api.fda.gov
Surgtech, Inc.Westlake, OH, United StatesManufacturer, Specification developer1February 21, 2017000api.fda.gov
SportCareHidalgo, TX, United StatesSpecification developer1January 5, 2021000api.fda.gov
Tigon Medical LLCMillersville, MD, United StatesManufacturer, Specification developer1October 29, 2024000api.fda.gov
Trax Surgical, Inc.Stoughton, MA, United StatesManufacturer1September 15, 2023000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler1March 20, 2003000api.fda.gov
TranS1Magnolia, TX, United StatesComplaint file establishment, Specification developer1November 7, 2012000api.fda.gov
Unified Spine, LLCWesterville, OH, United StatesManufacturer, Specification developer1January 31, 2007000api.fda.gov
Voom Medical Devices, LLCBrentwood, TN, United StatesComplaint file establishment, Manufacturer1February 28, 2023000api.fda.gov
3D MEDICAL MANUFACTURING, INC. (dba Tecomet)Riviera Beach, FL, United StatesContract manufacturer0000api.fda.gov
4web Inc.Frisco, TX, United StatesSpecification developer0000api.fda.gov
Alden Tool Company, Inc.Berlin, CT, United StatesContract manufacturer0000api.fda.gov
Alevio, LLCCullman, AL, United StatesManufacturer0000api.fda.gov
Alto Development Corp.Farmingdale, NJ, United StatesSpecification developer0000api.fda.gov
American Manufacturing And EngineeringMontgomeryville, PA, United StatesContract manufacturer0000api.fda.gov
Arcamed, LLCIndianapolis, IN, United StatesContract manufacturer0000api.fda.gov
ARCH - QuakertownQuakertown, PA, United StatesContract manufacturer0000api.fda.gov
Arch Medical Solutions - Philadelphia, LLC Dba Jade Precision Medical ComponentsHuntingdon Valley, PA, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - ElmhurstElmhurst, IL, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - MemphisBartlett, TN, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - MemphisLexington, TN, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - WarsawWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
ARCH-MedTorqueKenosha, WI, United StatesContract manufacturer0000api.fda.gov
Artifex Solutions, LLCSan Juan, PR, United StatesContract manufacturer0000api.fda.gov
Autocam MedicalKentwood, MI, United StatesContract manufacturer0000api.fda.gov
Autocam MedicalPlymouth, MA, United StatesContract manufacturer0000api.fda.gov
Avalign Integrated Medical Solutions, IncMentor, OH, United StatesContract manufacturer0000api.fda.gov
Axial MedicalIvyland, PA, United StatesContract manufacturer0000api.fda.gov
Able Medical DevicesMarquette, MI, United StatesManufacturer0000api.fda.gov
Acero PrecisionWest Chester, PA, United StatesContract manufacturer0000api.fda.gov
Acumed LLC -Brookwood FacilityHillsboro, OR, United StatesManufacturer0000api.fda.gov
Arthrex, Inc.Ave Maria, FL, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Autocam MedicalMurfreesboro, TN, United StatesContract manufacturer0000api.fda.gov
Avalign Delivery Systems DivisionGreenwood, IN, United StatesContract manufacturer0000api.fda.gov
Avalign Instruments & ImplantsFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
B & G MFG. Co.Hatfield, PA, United StatesContract manufacturer0000api.fda.gov
B & J Medical LLCKendallville, IN, United StatesContract manufacturer0000api.fda.gov
B-One Ortho, Corp.Cedar Knolls, NJ, United StatesManufacturer0000api.fda.gov
Boulder Biomed LLCBoulder, CO, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Branch Medical GroupEagleville, PA, United StatesContract manufacturer0000api.fda.gov
Branch Medical GroupLimerick, PA, United StatesContract manufacturer0000api.fda.gov
Bradshaw Medical Inc.Kenosha, WI, United StatesContract manufacturer0000api.fda.gov
C&W Swiss, Inc.Clayton, OH, United StatesContract manufacturer0000api.fda.gov
C-Axis IncHamel, MN, United StatesContract manufacturer0000api.fda.gov
C-Axis PR, IncCaguas, PR, United StatesContract manufacturer0000api.fda.gov
Cathtek LLCWalkertown, NC, United StatesContract manufacturer0000api.fda.gov
CB EnterprisesCanyon Country, CA, United StatesContract manufacturer0000api.fda.gov
Classic Wire Cut Company, Inc.Valencia, CA, United StatesContract manufacturer0000api.fda.gov
Conextions IncSalt Lake City, UT, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Curiteva, Inc.Tanner, AL, United StatesContract manufacturer0000api.fda.gov
Design Standards Corp.Charlestown, NH, United StatesContract manufacturer0000api.fda.gov
Donatelle Plastics, LLCNew Brighton, MN, United StatesContract manufacturer0000api.fda.gov
Donson Machine CompanyAlsip, IL, United StatesContract manufacturer0000api.fda.gov
DSM Biomedical, Inc.Exton, PA, United StatesContract manufacturer0000api.fda.gov
Eca Medical InstrumentsNewbury Park, CA, United StatesContract manufacturer0000api.fda.gov
Eminent Spine, LLCPlano, TX, United StatesContract manufacturer0000api.fda.gov
Eptam West LLCColorado Springs, CO, United StatesContract manufacturer0000api.fda.gov
Elite Medical, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Elite Medical, LLCFlorence, AL, United StatesContract manufacturer0000api.fda.gov
Elite Medical, LLCCordova, TN, United StatesContract manufacturer0000api.fda.gov
Engineered Medical Systems, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Ferry Machine CorporationOakland, NJ, United StatesContract manufacturer0000api.fda.gov
First Article IncSouderton, PA, United StatesContract manufacturer0000api.fda.gov
Five Star Manufacturing, Inc.New Bedford, MA, United StatesContract manufacturer0000api.fda.gov
Flex-Cell Precision, Inc.Lancaster, PA, United StatesContract manufacturer0000api.fda.gov
Fruh Packaging Inc.Exton, PA, United StatesContract manufacturer0000api.fda.gov
Fusion InnovationsMaitland, FL, United StatesSpecification developer0000api.fda.gov
Ferry Machine CorporationLittle Ferry, NJ, United StatesContract manufacturer0000api.fda.gov
Gauthier Biomedical, Inc.Grafton, WI, United StatesContract manufacturer0000api.fda.gov
General Machine, Inc.Colorado Springs, CO, United StatesContract manufacturer0000api.fda.gov
Geotec, Inc.Warwick, RI, United StatesContract manufacturer0000api.fda.gov
Guardian Medical Usa, IncSwanton, OH, United StatesContract manufacturer0000api.fda.gov
Harwood Design, Inc.Bristol, PA, United StatesContract manufacturer0000api.fda.gov
HG Medical Usa, LLCHolland, MI, United StatesContract manufacturer0000api.fda.gov
Huron Tool & Cutter GrindingFarmingdale, NY, United StatesContract manufacturer0000api.fda.gov
HyperFlex Medical IncRichmond, UT, United StatesSpecification developer0000api.fda.gov
Incipio DevicesHuntington, IN, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Instru-Med TechnologiesWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Implant Logistics / AMS MicromedicalSparta, WI, United StatesContract manufacturer0000api.fda.gov
Instrumed International Inc dba Avalign German Specialty InstrumentsSchaumburg, IL, United StatesContract manufacturer0000api.fda.gov
J & J Precision Technologies, LLCLititz, PA, United StatesContract manufacturer0000api.fda.gov
J&B Precision, Inc.Cordova, TN, United StatesContract manufacturer0000api.fda.gov
Janco, Inc.Rollinsford, NH, United StatesContract manufacturer0000api.fda.gov
Jatex, Inc.Nappanee, IN, United StatesContract manufacturer0000api.fda.gov
Jabil Inc. (Brandywine)W Chester, PA, United StatesContract manufacturer0000api.fda.gov
Jabil Inc. (Elmira)Horseheads, NY, United StatesContract manufacturer0000api.fda.gov
Jabil Inc. (Monument)Monument, CO, United StatesContract manufacturer0000api.fda.gov
Jabil Inc. (Wilson Drive)W Chester, PA, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Keystone ManufacturingKalamazoo, MI, United StatesContract manufacturer0000api.fda.gov
Kinamed, Inc.Camarillo, CA, United StatesManufacturer0000api.fda.gov
KLS Martin Manufacturing, LLCJacksonville, FL, United StatesContract manufacturer0000api.fda.gov
Leith Medical LLCAustin, TX, United StatesManufacturer0000api.fda.gov
LH Medical CorporationFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Life Science Outsourcing, Inc.Brea, CA, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Lifenet HealthVirginia Beach, VA, United StatesContract manufacturer0000api.fda.gov
LISI MEDICAL REmmeleBig Lake, MN, United StatesContract manufacturer0000api.fda.gov
LISI MEDICAL RemmeleCoon Rapids, MN, United StatesContract manufacturer0000api.fda.gov
Lowell,inc.Brooklyn Park, MN, United StatesContract manufacturer0000api.fda.gov
LaVezzi Precision, IncBloomingdale, IL, United StatesContract manufacturer0000api.fda.gov
Life Science OutsourcingSomersworth, NH, United StatesContract manufacturer0000api.fda.gov
LifeNet HealthVirginia Bch, VA, United StatesContract manufacturer0000api.fda.gov
LifeNet HealthPlainfield, IN, United StatesContract manufacturer0000api.fda.gov
Lincotek Medical LLCVandalia, OH, United StatesContract manufacturer0000api.fda.gov
Mackay Manufacturing, Inc.Spokane Valley, WA, United StatesContract manufacturer0000api.fda.gov
Mainstream Medical DevicesAustin, TX, United StatesContract manufacturer0000api.fda.gov
Maitland EngineeringSouth Bend, IN, United StatesContract manufacturer0000api.fda.gov
Matrix Machining Technologies, Inc.Memphis, TN, United StatesContract manufacturer0000api.fda.gov
Medical Device And Implants LLCLancaster, PA, United StatesContract manufacturer0000api.fda.gov
Medical Modeling - A 3D Systems CompanyLittleton, CO, United StatesContract manufacturer0000api.fda.gov
Medin Technologies, Inc.Totowa, NJ, United StatesContract manufacturer0000api.fda.gov
Medtech LLCMillington, TN, United StatesContract manufacturer0000api.fda.gov
MedulocDel Mar, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Micro Precision SwissSanta Ana, CA, United StatesContract manufacturer0000api.fda.gov
Micropulse IncColumbia City, IN, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.fda.gov
Mirus, LLCMarietta, GA, United StatesManufacturer0000api.fda.gov
Mount MFGMarquette, MI, United StatesContract manufacturer0000api.fda.gov
Maestro Logistics, LLCAustin, TX, United StatesContract manufacturer0000api.fda.gov
MendellLakeville, MN, United StatesContract manufacturer0000api.fda.gov
Metal Craft Machine & Engineering, Inc.Elk River, MN, United StatesContract manufacturer0000api.fda.gov
Microcision LLCPennsauken, NJ, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Netbiologics LLCLakewood Ranch, FL, United StatesManufacturer0000api.fda.gov
Nexxt Spine LLCNoblesville, IN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
NGInstruments, Inc dba Avalign Cutting InstrumentsWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Norman Noble, Inc.Highland Heights, OH, United StatesContract manufacturer0000api.fda.gov
Nuvasive, Inc.Guaynabo, PR, United StatesManufacturer0000api.fda.gov
NuVasive Specialized Orthopedics, Inc.Audubon, PA, United StatesManufacturer0000api.fda.gov
Oaktree AdditiveTampa, FL, United StatesContract manufacturer0000api.fda.gov
Odyssey Medical Technologies, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Onyx Medical LLCMemphis, TN, United StatesContract manufacturer0000api.fda.gov
Orchid Orthopedics-ChelseaChelsea, MI, United StatesContract manufacturer0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
Ortho Development Corp.Draper, UT, United StatesManufacturer for export0000api.fda.gov
Olive Branch Distribution CenterOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Orchid Orthopedic Solutions Alabama LLCArab, AL, United StatesContract manufacturer0000api.fda.gov
Pacific Instruments Inc.Honolulu, HI, United StatesContract manufacturer0000api.fda.gov
Paragon Medical, Inc.Pierceton, IN, United StatesContract manufacturer0000api.fda.gov
Perryman CompanyHouston, PA, United StatesContract manufacturer0000api.fda.gov
Phoenix Medical Products, Inc.Mountain City, TN, United StatesContract manufacturer0000api.fda.gov
Precision Edge Surgical Products CompanySault Sainte Marie, MI, United StatesContract manufacturer0000api.fda.gov
Precision Forms, Inc.Butler, NJ, United StatesContract manufacturer0000api.fda.gov
Precision Medical TechnologiesWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Precision Medical TechnologiesRome City, IN, United StatesContract manufacturer0000api.fda.gov
Precision One MedicalOceanside, CA, United StatesContract manufacturer0000api.fda.gov
Pro-Tech Design & MFG., Inc.Santa Fe Springs, CA, United StatesContract manufacturer0000api.fda.gov
PRO-TECH Design & Mfg, Inc.Arlington, TX, United StatesContract manufacturer0000api.fda.gov
Pulse Technologies, Inc.Quakertown, PA, United StatesContract manufacturer0000api.fda.gov
Paragon Medical Inc.Castleton, IN, United StatesContract manufacturer0000api.fda.gov
Paragon Medical Inc.Smithfield, UT, United StatesContract manufacturer0000api.fda.gov
Pioneer Surgical Technology, Inc.Marquette, MI, United StatesContract manufacturer, Manufacturer0030api.fda.gov
Precision Edge Surgical Products Co LLCBoyne City, MI, United StatesContract manufacturer0000api.fda.gov
Precision Edge Surgical Products, LLCAngola, IN, United StatesContract manufacturer0000api.fda.gov
Precision One MedicalHoover, AL, United StatesContract manufacturer0000api.fda.gov
Primo Medical Group, INCStoughton, MA, United StatesContract manufacturer0000api.fda.gov
Promethean Restorative Inc.Castle Rock, CO, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Quadm Technologies, LLCHamilton, NJ, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
R.K. ManufacturingDanbury, CT, United StatesContract manufacturer0000api.fda.gov
Ram Precision Industries IncDayton, OH, United StatesContract manufacturer0000api.fda.gov
Red Star Contract Manufacturing Inc.Larwill, IN, United StatesContract manufacturer0000api.fda.gov
Riverside Machine & Engineering, Inc.Eau Claire, WI, United StatesContract manufacturer0000api.fda.gov
RMS Co.Minneapolis, MN, United StatesContract manufacturer0000api.fda.gov
Resonetics, LLCBethel, CT, United StatesContract manufacturer0000api.fda.gov
RevZero, Inc.Chanhassen, MN, United StatesContract manufacturer0000api.fda.gov
SCT, Inc.Franklin Lakes, NJ, United StatesContract manufacturer0000api.fda.gov
Si-Bone, Inc.Santa Clara, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Si-Bone, Inc.Santa Clara, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Si-Technology, LLCWoodstock, GA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Sky SurgicalParkville, MO, United StatesComplaint file establishment, Specification developer0000api.fda.gov
SPINEFRONTIER, INC. DBA LESspine InnovationsBurlington, MA, United StatesManufacturer0000api.fda.gov
Steripack Usa (limited) LLCLakeland, FL, United StatesContract manufacturer0000api.fda.gov
Structure Medical, LLC.Naples, FL, United StatesContract manufacturer0000api.fda.gov
Surgical Instrument Manufacturers, LLCFenton, MO, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing IncClaypool, IN, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical, Inc. - ManchesterManchester, NH, United StatesContract manufacturer0000api.fda.gov
Sites Medical, LLCColumbia City, IN, United StatesContract manufacturer0000api.fda.gov
Spectrum Plastics GroupSaint Louis Park, MN, United StatesContract manufacturer0000api.fda.gov
Structure Medical, LLC.Mooresville, NC, United StatesContract manufacturer0000api.fda.gov
Summa Orthopaedics Inc.Berwyn, PA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Summit Orthopedic Technologies Inc.Naples, FL, United StatesContract manufacturer0000api.fda.gov
T & L Sharpening, Inc.Indiana Beach, IN, United StatesContract manufacturer0000api.fda.gov
TecometWoburn, MA, United StatesContract manufacturer0000api.fda.gov
Tesco Associates, Inc.Tyngsboro, MA, United StatesContract manufacturer0000api.fda.gov
Toby OrthopaedicsMiami, FL, United StatesManufacturer0000api.fda.gov
Turner Medical Inc.Athens, AL, United StatesContract manufacturer0000api.fda.gov
Tangible Solutions, Inc. DBA Marle Tangible, Inc.Fairborn, OH, United StatesContract manufacturer0000api.fda.gov
Tegra MedicalHernando, MS, United StatesContract manufacturer0000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
The E F PRECISION GROUPWillow Grove, PA, United StatesContract manufacturer0000api.fda.gov
Victoria Precision Inc.Trevose, PA, United StatesContract manufacturer0000api.fda.gov
Viant AS&O Holdings, LLCOrchard Park, NY, United StatesContract manufacturer0000api.fda.gov
Viant Medical, LLCFort Wayne, IN, United StatesContract manufacturer, Manufacturer for export0000api.fda.gov
Westwood Precision LLCAllentown, PA, United StatesContract manufacturer0000api.fda.gov
Watershed Idea Foundry, Inc.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Xenix MedicalOrlando, FL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
ZavationFlowood, MS, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Zien Medical Technologies LLCSalt Lake City, UT, United StatesContract manufacturer0000api.fda.gov
b-ONE Ortho Corp.Fairfield, NJ, United StatesSpecification developer0000api.fda.gov

Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.