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Data / Medical devices / Bit, Surgical / United States

FDA-registered makers of Bit, Surgical in the United States: 46 establishments

46 establishments in the United States are registered with the FDA to make Bit, Surgical (product code GFG). 0 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.

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Get makers of this device in the United StatesWatch these makers
Device
Bit, Surgical
Product code
GFG
Country
United States

Makers of Bit, Surgical in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
3D MEDICAL MANUFACTURING, INC. (dba Tecomet)Riviera Beach, FL, United StatesContract manufacturer0000api.fda.gov
Acumed LLCHillsboro, OR, United StatesSpecification developer0000api.fda.gov
ARCH Medical Solutions - WarsawWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Avalign Instruments & ImplantsFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
B & J Medical LLCKendallville, IN, United StatesContract manufacturer0000api.fda.gov
Centinel Spine, LLCWest Chester, PA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Classic Wire Cut Company, Inc.Valencia, CA, United StatesContract manufacturer0000api.fda.gov
Conmed CorporationUtica, NY, United StatesContract manufacturer0000api.fda.gov
DePuy Mitek, Inc.Raynham, MA, United StatesSpecification developer0000api.fda.gov
Jabil Inc. (Brandywine)W Chester, PA, United StatesContract manufacturer0000api.fda.gov
Jabil Inc. (Monument)Monument, CO, United StatesContract manufacturer0000api.fda.gov
Linvatec CorporationLargo, FL, United StatesManufacturer0000api.fda.gov
Mcginley Orthopaedic Innovations, IncCasper, WY, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Medipost, Inc.Cambridge, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Microport Orthopedics Inc.Arlington, TN, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Medartis Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
Medline ReNewalRedmond, OR, United StatesReprocessor0000api.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
Orthopediatrics, CorpWarsaw, IN, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Packaging Compliance Medical, LLCKentwood, MI, United StatesContract manufacturer0000api.fda.gov
Pilotis Tech LLCBrookhaven, GA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Precision Edge Surgical Products CompanySault Sainte Marie, MI, United StatesContract manufacturer0000api.fda.gov
Pro-Dex, Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Paragon Medical Inc.Smithfield, UT, United StatesContract manufacturer0000api.fda.gov
Pro-Dex IncTustin, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Responsive ArthroscopyMinneapolis, MN, United StatesSpecification developer0000api.fda.gov
RTI Surgical, Inc. (dba RTI Biologics, Inc.)Alachua, FL, United StatesSpecification developer0000api.fda.gov
Smith & Nephew Inc.Andover, MA, United StatesSpecification developer0000api.fda.gov
Smith & Nephew Inc.Mansfield, MA, United StatesSpecification developer0010api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesManufacturer0000api.fda.gov
Symmetry Medical Manufacturing IncClaypool, IN, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Symmetry Medical Manufacturing Inc.Warsaw, IN, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Structure Medical, LLC.Mooresville, NC, United StatesContract manufacturer0000api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesSpecification developer0000api.fda.gov
TORNIER Inc.Columbia City, IN, United StatesSpecification developer0000api.fda.gov
VorzeigenConnersville, IN, United StatesContract manufacturer0000api.fda.gov
Viant AS&O Holdings, LLCLaconia, NH, United StatesContract manufacturer0000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesManufacturer0000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Zentech Inc.Clearwater, FL, 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.