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Data / Medical devices / Washer, Bolt Nut / United States

FDA-registered makers of Washer, Bolt Nut in the United States: 123 establishments

123 establishments in the United States are registered with the FDA to make Washer, Bolt Nut (product code HTN). 33 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.

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Device
Washer, Bolt Nut
Product code
HTN
Country
United States

Makers of Washer, Bolt Nut in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Arthrex, Inc.Naples, FL, United StatesSpecification developer14December 22, 2025010api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesComplaint file establishment, Specification developer9April 6, 2020000api.fda.gov
Acumed LLCHillsboro, OR, United StatesManufacturer, Specification developer4January 23, 2025000api.fda.gov
Smith & Nephew Inc.Andover, MA, United StatesSpecification developer4March 12, 2019000api.fda.gov
Smith & Nephew Inc.Mansfield, MA, United StatesManufacturer, Specification developer4March 12, 2019000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesContract manufacturer, Manufacturer3July 18, 2014000api.fda.gov
Linvatec CorporationLargo, FL, United StatesManufacturer3June 28, 2019000api.fda.gov
Arthrosurface, Inc.W Bridgewater, MA, United StatesManufacturer2May 3, 2017000api.fda.gov
Arthrex Logistic CenterFort Myers, FL, United StatesManufacturer2August 6, 2009000api.fda.gov
Arthrex Manufacturing Inc.Pendleton, SC, United StatesContract manufacturer, Contract sterilizer, Manufacturer2August 6, 2009000api.fda.gov
Depuy Orthopaedics, Inc.Warsaw, IN, United StatesSpecification developer2July 24, 1991000api.fda.gov
Pioneer Surgical Technology, Inc.Marquette, MI, United StatesManufacturer2February 8, 2001000api.fda.gov
Trimed, Inc.Santa Clarita, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer2July 11, 2025010api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesManufacturer2October 29, 2025000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesComplaint file establishment, Specification developer2October 29, 2025000api.fda.gov
Acumed LLC -Brookwood FacilityHillsboro, OR, United StatesManufacturer1January 23, 2025000api.fda.gov
Biopro, Inc.Port Huron, MI, United StatesManufacturer1October 24, 2013000api.fda.gov
Depuy Spine, Inc.Raynham, MA, United StatesSpecification developer1April 27, 1988000api.fda.gov
DePuy Mitek, Inc.Raynham, MA, United StatesSpecification developer1December 18, 1998000api.fda.gov
Fusion Orthopedics Usa, LLCMesa, AZ, United StatesComplaint file establishment, Specification developer1December 23, 2024000api.fda.gov
Globus Medical, Inc.Audubon, PA, United StatesManufacturer1June 3, 2024000api.fda.gov
Globus Medical, Inc.Memphis, TN, United StatesManufacturer1June 3, 2024000api.fda.gov
In2bones Usa, LLCCordova, TN, United StatesManufacturer, Specification developer1March 31, 2022000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer1December 10, 2021000api.fda.gov
Orthonovis, Inc.Palm Coast, FL, United StatesManufacturer, Repackager or relabeler, Specification developer1February 2, 2016000api.fda.gov
Orthopedic Designs North America, Inc.Tampa, FL, United StatesManufacturer1April 1, 2003000api.fda.gov
Smith & Nephew Inc.Oklahoma City, OK, United StatesManufacturer1March 12, 2019000api.fda.gov
Stryker Puerto Rico, LLC.Arroyo, PR, United StatesContract manufacturer, Manufacturer1October 29, 2025000api.fda.gov
The Orthopaedic Implant CompanyReno, NV, United StatesSpecification developer1February 2, 2024000api.fda.gov
TORNIER Inc.Columbia City, IN, United StatesSpecification developer1January 3, 2014000api.fda.gov
Tornier, Inc.Bloomington, MN, United StatesComplaint file establishment, Manufacturer1January 3, 2014000api.fda.gov
Vilex LLCMcminnville, TN, United StatesManufacturer1August 1, 2024000api.fda.gov
Zimmer, Inc.Warsaw, IN, United StatesContract manufacturer, Manufacturer1September 11, 2009010api.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
Arcamed, LLCIndianapolis, IN, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - WarsawWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
ARCH-MedTorqueKenosha, WI, 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
Arthrex, Inc.Ave Maria, FL, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
B & G MFG. Co.Hatfield, PA, United StatesContract manufacturer0000api.fda.gov
B & J Medical LLCKendallville, IN, United StatesContract manufacturer0000api.fda.gov
Biomet MicrofixationJacksonville, FL, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
C&W Swiss, Inc.Clayton, OH, United StatesContract manufacturer0000api.fda.gov
Chest Wall Innovations, Inc.Hummelstown, PA, United StatesSpecification developer0000api.fda.gov
Conextions IncSalt Lake City, UT, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Culver Tool & EngineeringPlymouth, IN, United StatesContract manufacturer0000api.fda.gov
Curvafix, Inc.Kirkland, WA, United StatesManufacturer0000api.fda.gov
Design Standards Corp.Charlestown, NH, United StatesContract manufacturer0000api.fda.gov
Dunamis Medical LLCGreenville, AL, United StatesManufacturer, Specification developer0000api.fda.gov
Eptam West LLCColorado Springs, CO, United StatesContract manufacturer0000api.fda.gov
Engineered Medical Systems, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Extremity Medical, LLCParsippany, NJ, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
FLOWER ORTHOPEDICS CORPORATION DBA Conventus FlowerHorsham, PA, United StatesSpecification developer0000api.fda.gov
Gramercy Extremity Orthopedics, LLC.Richardson, TX, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.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
Implant Logistics / AMS MicromedicalSparta, WI, 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. (Monument)Monument, CO, United StatesContract manufacturer0000api.fda.gov
Kyocera Medical Technologies, Inc.Redlands, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Life Science Outsourcing, Inc.Brea, CA, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Mahe Medical UsaLaramie, WY, United StatesComplaint file establishment, Specification developer0000api.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
Medical Surgical, Inc.Andover, MN, United StatesSpecification developer0000api.fda.gov
Medin Technologies, Inc.Totowa, NJ, United StatesContract manufacturer0000api.fda.gov
Medshape, Inc.Atlanta, GA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Medtech LLCMillington, TN, United StatesContract manufacturer0000api.fda.gov
Micro Precision SwissSanta Ana, CA, 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
Maestro Logistics, LLCAustin, TX, United StatesContract manufacturer0000api.fda.gov
NGInstruments, Inc dba Avalign Cutting InstrumentsWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Onyx Medical LLCMemphis, TN, United StatesContract manufacturer0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
Ortho Outcomes, LLCSalt Lake City, UT, United StatesSpecification developer0000api.fda.gov
Orthopediatrics, CorpWarsaw, IN, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
OsteomedAddison, TX, United StatesManufacturer0000api.fda.gov
OsteoCentric Technologies,IncLogan, UT, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Pace SurgicalMalvern, PA, United StatesSpecification developer0000api.fda.gov
Packaging Compliance Medical, LLCKentwood, MI, United StatesContract manufacturer0000api.fda.gov
Paragon 28Englewood, CO, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Parcus Medical, L.L.C.Sarasota, FL, United StatesManufacturer0000api.fda.gov
Praxis Powder Technology, Inc.Queensbury, NY, United StatesContract manufacturer0000api.fda.gov
Precision Edge Surgical Products CompanySault Sainte Marie, MI, United StatesContract manufacturer0000api.fda.gov
Precision Medical TechnologiesWarsaw, IN, 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
Primo Medical Group, INCStoughton, MA, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
R.K. ManufacturingDanbury, CT, United StatesContract manufacturer0000api.fda.gov
Riverpoint Medical LLCPortland, OR, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
RMS Co.Minneapolis, MN, United StatesContract manufacturer0000api.fda.gov
Robling Medical, LLCYoungsville, NC, United StatesContract manufacturer0000api.fda.gov
Resonetics, LLCBethel, CT, United StatesContract manufacturer0000api.fda.gov
RevZero, Inc.Chanhassen, MN, United StatesContract manufacturer0000api.fda.gov
Single Source Medical LLCChurubusco, IN, United StatesManufacturer for export0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Structure Medical, LLC.Naples, FL, United StatesContract manufacturer0000api.fda.gov
Surgical Instrument Manufacturers, LLCFenton, MO, United StatesContract manufacturer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.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
T & L Sharpening, Inc.Indiana Beach, IN, United StatesContract manufacturer0000api.fda.gov
Trax Surgical, Inc.Stoughton, MA, United StatesManufacturer0000api.fda.gov
Tangible Solutions, Inc. DBA Marle Tangible, Inc.Fairborn, OH, United StatesContract manufacturer0000api.fda.gov
Tegra MedicalHernando, MS, United StatesContract manufacturer0000api.fda.gov
Trilliant Surgical LLCHouston, TX, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Tyber MedicalBethlehem, PA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Tyber MedicalBethlehem, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
Westwood Precision LLCAllentown, PA, United StatesContract manufacturer0000api.fda.gov
Zien Medical Technologies LLCSalt Lake City, UT, United StatesContract manufacturer0000api.fda.gov
Zimmer Manufacturing B.V.Mercedita, PR, United StatesManufacturer0000api.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.