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Data / Medical devices / Driver, Surgical, Pin

Driver, Surgical, Pin (GFC): 74 FDA-registered makers in 7 countries

74 establishments in 7 countries are registered with the FDA to make Driver, Surgical, Pin (product code GFC, Class 1, 21 CFR 878.4820). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on September 27, 1978, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Product code
GFC
Device class
1
Regulation
878.4820
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
United States42
Germany11
China9
Pakistan6
Switzerland3
Mexico2
South Korea1

Makers of Driver, Surgical, Pin

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Aap Implantate AGBerlin, GermanyManufacturer0000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Armbruster GMBHSteinach Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Apex (Guangzhou) Tools & Orthopedics CompanyGuangzhou Guangdong, ChinaContract manufacturer0000api.fda.gov
Autocam MedicalMurfreesboro, TN, 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
B. Ali ImpexSIALKOT, Punjab, PakistanManufacturer0000api.fda.gov
Baechler Feintech AGHoelstein Basel-Landschaft, SwitzerlandContract manufacturer0000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer0000api.fda.gov
Berger Surgical Medical Products GmbHNeuhausen ob Eck Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
CELESTICA de MONTERREY S.A. de C.V.Apodaca Nuevo Leon, MexicoContract manufacturer0000api.fda.gov
CM Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Depuy Spine, Inc.Raynham, MA, United StatesSpecification developer0000api.fda.gov
Dimeda Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Dongguan City Ruimi Gift Products Co LtdDongguan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Emerald InstrumentsSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Endo Tech InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Erchinger AGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Five Star Manufacturing, Inc.New Bedford, MA, United StatesContract manufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Garish ApparelsWazirabad Punjab, PakistanManufacturer0000api.fda.gov
Gauthier Biomedical, Inc.Grafton, WI, United StatesContract manufacturer0000api.fda.gov
Gebr. Brasseler GMBH & Co. KGLEMGO North Rhine-Westphalia, GermanyManufacturer0000api.fda.gov
GS Medical Co., Ltd.Heungdeok-gu, Cheongju-si Chungbuk, South KoreaManufacturer0000api.fda.gov
Guangdong Comfort Medical Products Co., Ltd.Jiangmen Guangdong, ChinaManufacturer0000api.fda.gov
Guangzhou Aquila Precise Tools LimitedGuangzhou City Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Guizhou Zirui Technology Co., Ltd.Tongzi County, Zunyi Guizhou, ChinaManufacturer0000api.fda.gov
Hangzhou Rollmed Co.,ltd.Hangzhou Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Highridge Medical, LLCWestminster, CO, United StatesSpecification developer0000api.fda.gov
Instru-Med TechnologiesWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Insurgical, Inc.Austin, TX, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Jabil Inc. (Brandywine)W Chester, PA, United StatesContract manufacturer0000api.fda.gov
LISI MEDICAL RemmeleCoon Rapids, MN, United StatesContract manufacturer0000api.fda.gov
Mahe Medical UsaLaramie, WY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Manufacturing Technology And Services, LLCOxford, AL, United StatesContract manufacturer0000api.fda.gov
Maxx Orthopedics Inc.Norristown, PA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Medcare Solutions GMBHEmmingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
MK medical GmbHEmmingen-Liptingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Medartis Inc.Warsaw, IN, 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
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Nextcon InternationalSialkot Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Ningbo Tianbo First Aid Product Co., Ltd.Ningbo Zhejiang, ChinaManufacturer0000api.fda.gov
Nvision Biomedical Technologies, IncSan Antonio, TX, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Orthopediatrics, CorpWarsaw, IN, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Olive Branch Distribution CenterOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Pacific Instruments Inc.Honolulu, HI, United StatesContract manufacturer0000api.fda.gov
Packaging Compliance Medical, LLCKentwood, MI, United StatesContract manufacturer0000api.fda.gov
Precision Medical TechnologiesWarsaw, 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
Shalby Advanced Technologies, Inc.El Dorado Hills, 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
Synthes GMBHZuchwil Solothurn, SwitzerlandSpecification developer0000api.fda.gov
SYNTHES GMBH / Synthes Produktions GmbHOberdorf, Baselland Basel-Landschaft, SwitzerlandManufacturer0000api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesSpecification developer0000api.fda.gov
Tecomet, Inc.Kenosha, WI, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Tedan Surgical Innovations, Inc.Sugar Land, TX, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Trigon America LLCAurora, IL, United StatesContract manufacturer0000api.fda.gov
Trimed, Inc.Santa Clarita, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Troy Innovative Instruments Co LLCMiddlefield, OH, United StatesContract manufacturer0000api.fda.gov
Twin City Edm And MFG IncFridley, MN, United StatesContract manufacturer0000api.fda.gov
Unity Tool, Inc.Osseo, MN, United StatesContract manufacturer0000api.fda.gov
Vilex LLCMcminnville, TN, United StatesManufacturer0000api.fda.gov
Xtant Medical Holdings, Inc.Belgrade, MT, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Yiwu Ori-Power Medtech Co., Ltd.YIWU Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Zepf Medical Instruments GMBHSEITINGEN-OBERFLACHT Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Zimmer, Inc.Warsaw, IN, United StatesManufacturer0010api.fda.gov
Zhejiang Biomet Medical Products Co., Ltd.Jinhua Zhejiang, ChinaContract manufacturer0000api.fda.gov

Updated September 27, 1978. 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.