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Data / Medical devices / Appliance, Fixation, Spinal Intervertebral Body / United States

FDA-registered makers of Appliance, Fixation, Spinal Intervertebral Body in the United States: 218 establishments

218 establishments in the United States are registered with the FDA to make Appliance, Fixation, Spinal Intervertebral Body (product code KWQ). 76 have a 510(k) clearance or PMA approval on file and 13 have a recall event. FDA data exported November 3, 2026.

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Device
Appliance, Fixation, Spinal Intervertebral Body
Product code
KWQ
Country
United States

Makers of Appliance, Fixation, Spinal Intervertebral Body in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesRepackager or relabeler, Specification developer32November 12, 2015040api.fda.gov
Highridge Medical, LLCWestminster, CO, United StatesSpecification developer31October 8, 2020030api.fda.gov
Warsaw Orthopedic, Inc.Warsaw, IN, United StatesManufacturer, Repackager or relabeler31November 12, 2015000api.fda.gov
Depuy Spine, Inc.Raynham, MA, United StatesSpecification developer30September 6, 2013020api.fda.gov
Globus Medical, Inc.Memphis, TN, United StatesManufacturer27November 3, 2021000api.fda.gov
Nuvasive, Inc.San Diego, CA, United StatesComplaint file establishment, Manufacturer, Specification developer27November 3, 2021000api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesComplaint file establishment, Specification developer25December 2, 2015010api.fda.gov
Medtronic Puerto Rico Operations Co., HumacaoHumacao, PR, United StatesManufacturer23November 12, 2015000api.fda.gov
Orthofix Us LLCLewisville, TX, United StatesComplaint file establishment, Manufacturer, Specification developer19February 11, 2022010api.fda.gov
K2M, Inc.Leesburg, VA, United StatesComplaint file establishment, Manufacturer, Specification developer18November 7, 2024000api.fda.gov
Depuy OrthopaedicsBridgewater, MA, United StatesManufacturer, Repackager or relabeler16September 6, 2013000api.fda.gov
Xtant Medical Holdings, Inc.Belgrade, MT, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer15June 23, 2021000api.fda.gov
Globus Medical, Inc.Audubon, PA, United StatesManufacturer14January 25, 2024000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesManufacturer, Repackager or relabeler13November 12, 2015000api.fda.gov
Seaspine Orthopedics CorporationCarlsbad, CA, United StatesComplaint file establishment, Manufacturer, Specification developer12September 1, 2021000api.fda.gov
ZavationFlowood, MS, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Specification developer12November 4, 2020000api.fda.gov
Spinal Elements, Inc.Carlsbad, CA, United StatesComplaint file establishment, Manufacturer11August 2, 2023000api.fda.gov
Stryker SpineAllendale, NJ, United StatesComplaint file establishment, Manufacturer, Specification developer10November 7, 2024040api.fda.gov
Life SpineHuntley, IL, United StatesSpecification developer9December 11, 2024000api.fda.gov
Precision Spine, Inc.Pearl, MS, United StatesManufacturer9March 16, 2022000api.fda.gov
Alphatec Spine, Inc.Carlsbad, CA, United StatesManufacturer, Specification developer8August 28, 2025040api.fda.gov
Alphatec Spine, Inc.Memphis, TN, United StatesManufacturer7August 28, 2025000api.fda.gov
Choice Spine LLCKnoxville, TN, United StatesComplaint file establishment, Specification developer6May 1, 2019000api.fda.gov
Genesys SpineAustin, TX, United StatesManufacturer6October 24, 2019010api.fda.gov
Nuvasive, Inc.Guaynabo, PR, United StatesManufacturer5November 3, 2021000api.fda.gov
TranS1Magnolia, TX, United StatesComplaint file establishment, Specification developer5November 20, 2019000api.fda.gov
CTL Medical CorporationCarrollton, TX, United StatesComplaint file establishment, Manufacturer, Specification developer4January 26, 2024000api.fda.gov
Eminent Spine, LLCPlano, TX, United StatesManufacturer4August 25, 2020000api.fda.gov
Evolution Spine, LLCDallas, TX, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer4March 18, 2022000api.fda.gov
Kyocera Medical Technologies, Inc.Redlands, CA, United StatesComplaint file establishment, Specification developer4April 10, 2025000api.fda.gov
Nexxt Spine LLCNoblesville, IN, United StatesComplaint file establishment, Manufacturer4March 22, 2024000api.fda.gov
Altus PartnersWest Chester, PA, United StatesRepackager or relabeler, Specification developer3May 29, 2019000api.fda.gov
Carlsmed, Inc.Carlsbad, CA, United StatesComplaint file establishment, Manufacturer3September 24, 2026000api.fda.gov
Curiteva, Inc.Tanner, AL, United StatesContract manufacturer, Manufacturer3February 29, 2024000api.fda.gov
Degen MedicalFlorence, SC, United StatesComplaint file establishment, Specification developer3January 7, 2022000api.fda.gov
INNO Holdings Inc.Millcreek, UT, United StatesManufacturer3November 8, 2019020api.fda.gov
Mirus, LLCMarietta, GA, United StatesManufacturer3May 17, 2024000api.fda.gov
Nexus Spine, L.L.C.Salt Lake City, UT, United StatesComplaint file establishment, Specification developer3February 2, 2023000api.fda.gov
Nexus Spine, LLC.Lehi, UT, United StatesSpecification developer3February 2, 2023000api.fda.gov
Nvision Biomedical Technologies, IncSan Antonio, TX, United StatesRepackager or relabeler, Specification developer3October 22, 2021000api.fda.gov
Spinecraft LLCWestmont, IL, United StatesManufacturer, Specification developer3March 4, 2026000api.fda.gov
Vy Spine, LLCBountiful, UT, United StatesManufacturer, Specification developer3March 27, 2026000api.fda.gov
4web Inc.Frisco, TX, United StatesSpecification developer2May 17, 2022000api.fda.gov
Atlas Spine Inc.Jupiter, FL, United StatesManufacturer2November 29, 2018000api.fda.gov
Camber Spine TechnologiesKing of Prussia, PA, United StatesComplaint file establishment, Manufacturer, Specification developer2April 16, 2024000api.fda.gov
CAPTIVA SPINE, Inc.Jupiter, FL, United StatesComplaint file establishment, Specification developer2June 11, 2015020api.fda.gov
Kalitec Direct LLC DBA Kalitec MedicalSarasota, FL, United StatesComplaint file establishment, Repackager or relabeler, Specification developer2September 22, 2017000api.fda.gov
Nanovis Spine, LLCColumbia City, IN, United StatesManufacturer, Specification developer2October 26, 2016000api.fda.gov
Paramount Surgicals, Inc.Brownsville, TX, United StatesRepackager or relabeler, Specification developer2April 16, 2007000api.fda.gov
Pioneer Surgical Technology, Inc.Marquette, MI, United StatesContract manufacturer, Manufacturer2June 20, 2023010api.fda.gov
Precision Medical Technologies- North Manchester Manufacturing FacilityN Manchester, IN, United StatesManufacturer2January 19, 2010000api.fda.gov
Southern Spine, LLCMacon, GA, United StatesSpecification developer2May 16, 2007000api.fda.gov
Teslake, Inc.San Diego, CA, United StatesSpecification developer2May 31, 2019000api.fda.gov
Ulrich Medical Usa, Inc.Plano, TX, United StatesSpecification developer2March 18, 2024010api.fda.gov
UOC USA Inc.Irvine, CA, United StatesManufacturer, Manufacturer for export2February 18, 2000000api.fda.gov
Aegis Meditec, Inc.Costa Mesa, CA, United StatesSpecification developer1January 11, 2023000api.fda.gov
ARCH Medical Solutions - Escondido LLCEscondido, CA, United StatesManufacturer1July 21, 2010000api.fda.gov
Aurora Spine, Inc.Carlsbad, CA, United StatesComplaint file establishment, Specification developer1March 23, 2021000api.fda.gov
Astura MedicalIrving, TX, United StatesComplaint file establishment, Specification developer1August 23, 2016000api.fda.gov
Deroyal Industries, Inc.Powell, TN, United StatesComplaint file establishment, Specification developer1December 22, 2009000api.fda.gov
Expanding Innovations, Inc.Mountain View, CA, United StatesComplaint file establishment, Manufacturer1May 20, 2025000api.fda.gov
Flospine LLCBoca Raton, FL, United StatesManufacturer1April 7, 2021000api.fda.gov
G Surgical LLCAustin, TX, United StatesManufacturer, Repackager or relabeler, Specification developer1January 12, 2011000api.fda.gov
Met One Technologies, LLCEl Paso, TX, United StatesManufacturer, Specification developer1December 17, 2018000api.fda.gov
Medynus, Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer, Specification developer1March 3, 2022000api.fda.gov
Ortho Development Corp.Draper, UT, United StatesComplaint file establishment, Manufacturer1April 5, 2002000api.fda.gov
Osseus Fusion Systems LLCDallas, TX, United StatesRepackager or relabeler, Specification developer1April 26, 2016000api.fda.gov
Omnia MedicalMorgantown, WV, United StatesSpecification developer1December 22, 2016000api.fda.gov
Rhausler, Inc.Fremont, CA, United StatesSpecification developer1February 7, 2005000api.fda.gov
RSB Spine LLC.Wooster, OH, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer1October 6, 2009000api.fda.gov
Spinal Simplicity, LLCOverland Park, KS, United StatesComplaint file establishment, Specification developer1May 24, 2024000api.fda.gov
SpineNet LLCMaitland, FL, United StatesSpecification developer1February 5, 2020000api.fda.gov
SpineSmith Holdings, LLCAustin, TX, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer1July 14, 2008000api.fda.gov
Unified Spine, LLCWesterville, OH, United StatesManufacturer, Specification developer1July 25, 2011000api.fda.gov
Valorus Spine, LLCDanville, CA, United StatesManufacturer1October 23, 2017000api.fda.gov
Xenco Medical LLCSan Diego, CA, United StatesComplaint file establishment, Manufacturer, Specification developer1December 21, 2021000api.fda.gov
3D MEDICAL MANUFACTURING, INC. (dba Tecomet)Riviera Beach, FL, United StatesContract manufacturer0000api.fda.gov
Alden Tool Company, Inc.Berlin, CT, United StatesContract manufacturer0000api.fda.gov
American Manufacturing And EngineeringMontgomeryville, PA, United StatesContract manufacturer0000api.fda.gov
Ar FabricatingGeorgetown, TX, 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 - Olive BranchOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - SeabrookSeabrook, NH, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - WarsawWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
ARCH-MedTorqueKenosha, WI, United StatesContract manufacturer0000api.fda.gov
Argon Medical Devices, Inc.Wheeling, IL, 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
Acero PrecisionWest Chester, PA, United StatesContract manufacturer0000api.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
Banister Tool, Inc.Pflugerville, TX, United StatesContract manufacturer0000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer0000api.fda.gov
Biopro, Inc.Port Huron, MI, United StatesContract manufacturer0000api.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&A Tool Engineering, Inc. Auburn PlantAuburn, IN, United StatesContract manufacturer0000api.fda.gov
C&W Swiss, Inc.Clayton, OH, United StatesContract manufacturer0000api.fda.gov
C+a Tool Engineering, Inc.Churubusco, IN, United StatesContract manufacturer0000api.fda.gov
Cep Bio-Coat, LLCFarmington Hills, MI, United StatesContract manufacturer0000api.fda.gov
Classic Wire Cut Company, Inc.Valencia, CA, United StatesContract manufacturer0000api.fda.gov
Culver Tool & EngineeringPlymouth, IN, United StatesContract manufacturer0000api.fda.gov
Complexus MedicalMishawaka, IN, United StatesContract manufacturer0000api.fda.gov
Donatelle Plastics, LLCNew Brighton, MN, United StatesContract manufacturer0000api.fda.gov
Donson Machine CompanyAlsip, IL, United StatesContract manufacturer0000api.fda.gov
Elevation SpineMonterey, CA, United StatesSpecification developer0000api.fda.gov
Eptam Plastics, LtdNorthfield, NH, 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
Flex-Cell Precision, Inc.Lancaster, PA, United StatesContract manufacturer0000api.fda.gov
Fort Wayne Metals Research Products, LLCFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Ferry Machine CorporationLittle Ferry, NJ, United StatesContract manufacturer0000api.fda.gov
Gauthier Biomedical, Inc.Grafton, WI, United StatesContract manufacturer0000api.fda.gov
Hammill MFG. Co.Maumee, OH, United StatesContract manufacturer0000api.fda.gov
Harwood Design, Inc.Bristol, PA, United StatesContract manufacturer0000api.fda.gov
Hoosier, Inc.Corona, CA, United StatesContract manufacturer0000api.fda.gov
Incipio DevicesHuntington, IN, United StatesContract manufacturer0000api.fda.gov
Insert Molding Solutions, Inc.Cumming, GA, United StatesContract manufacturer0000api.fda.gov
Instru-Med TechnologiesWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Isotis Orthobiologics, IncIrvine, CA, 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
Jarvis Surgical Inc.Westfield, MA, 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
LH Medical CorporationFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Life Science Outsourcing, Inc.Brea, CA, United StatesContract manufacturer, Contract sterilizer0000api.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
Mach MedicalColumbia City, IN, United StatesContract manufacturer0000api.fda.gov
Mackay Manufacturing, Inc.Spokane Valley, WA, United StatesContract manufacturer0000api.fda.gov
Mahe Medical UsaLaramie, WY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Mainstream Medical DevicesAustin, TX, United StatesContract manufacturer0000api.fda.gov
Medical Component SpecialistsBellingham, MA, United StatesContract manufacturer0000api.fda.gov
Medical Device And Implants LLCLancaster, PA, United StatesContract manufacturer0000api.fda.gov
Medtech LLCMillington, TN, United StatesContract manufacturer0000api.fda.gov
Medtronic Xomed, Inc.Jacksonville, FL, United StatesManufacturer0000api.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
Mount MFGMarquette, MI, United StatesContract manufacturer0000api.fda.gov
Machining Midtown LLCAtlanta, GA, 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
Ngage Medical ManufacturingHernando, MS, United StatesContract manufacturer0000api.fda.gov
NGInstruments, Inc dba Avalign Cutting InstrumentsWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
NML Medical, LLCWest Carrollton, OH, United StatesContract manufacturer0000api.fda.gov
Norwood Medical LLCDayton, OH, United StatesContract manufacturer0000api.fda.gov
Novus Manufacturing SolutionsMurfreesboro, TN, United StatesContract manufacturer0000api.fda.gov
Oberg Medical Products CompanySarver, PA, United StatesContract manufacturer0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
Olive Branch Distribution CenterOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Orchid Orthopedic Solutions Alabama LLCArab, AL, United StatesContract manufacturer0000api.fda.gov
P&F MachiningOtsego, MN, 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
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
Pulse Technologies, Inc.Quakertown, PA, United StatesContract manufacturer0000api.fda.gov
Pantheon Spinal LLCGeorgetown, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Paragon Medical - DaytonDayton, OH, 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
Phillips Precision IncElmwood Park, NJ, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Remington Medical, Inc.Alpharetta, GA, 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
Remington Medical, Inc.Alpharetta, GA, United StatesContract manufacturer0000api.fda.gov
RevZero, Inc.Chanhassen, MN, United StatesContract manufacturer0000api.fda.gov
SPINEFRONTIER, INC. DBA LESspine InnovationsBurlington, MA, United StatesManufacturer0010api.fda.gov
Stoll Metalcraft, Inc.Santa Clarita, CA, 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
Structure Medical, LLC.Mooresville, NC, United StatesContract manufacturer0000api.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
TOMZ CorporationBerlin, CT, United StatesContract manufacturer0000api.fda.gov
Troy Innovative Instruments Co LLCMiddlefield, OH, United StatesContract manufacturer0000api.fda.gov
Turnco Tool & Instrument, Inc.Georgetown, TX, United StatesContract manufacturer0000api.fda.gov
Turner Medical Inc.Athens, AL, United StatesContract manufacturer0000api.fda.gov
Tech Industries. Inc.Cleveland, OH, United StatesContract manufacturer0000api.fda.gov
Tecomet, Inc.Wilmington, MA, United StatesContract manufacturer0000api.fda.gov
Tegra MedicalHernando, MS, United StatesContract manufacturer0000api.fda.gov
The E F PRECISION GROUPWillow Grove, PA, United StatesContract manufacturer0000api.fda.gov
Titan Spine, a Division of MedtronicMilwaukee, WI, United StatesManufacturer0000api.fda.gov
Victoria Precision Inc.Trevose, PA, United StatesContract manufacturer0000api.fda.gov
VorzeigenConnersville, IN, United StatesContract manufacturer0000api.fda.gov
Viant AS&O Holdings, LLCIndianapolis, IN, United StatesContract manufacturer0000api.fda.gov
Viant AS&O Holdings, LLCOrchard Park, NY, United StatesContract manufacturer0000api.fda.gov
Westwood Precision LLCAllentown, PA, United StatesContract manufacturer0000api.fda.gov
Watershed Idea Foundry, Inc.Carlsbad, CA, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Xenix MedicalOrlando, FL, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Zigg Design LLCNibley, UT, United StatesContract manufacturer0000api.fda.gov
rms SurgicalAnoka, MN, United StatesContract manufacturer0000api.fda.gov

Updated November 3, 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.