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Data / Medical devices / Corkscrew

Corkscrew (HWI): 28 FDA-registered makers in 9 countries

28 establishments in 9 countries are registered with the FDA to make Corkscrew (product code HWI, Class 1, 21 CFR 888.4540). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on March 2, 1988, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
HWI
Device class
1
Regulation
888.4540
Medical specialty
Orthopedic

Makers by country

CountryMakers
United States18
Germany2
India2
China1
South Korea1
Pakistan1
France1
Mexico1
Brazil1

Makers of Corkscrew

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
Aegis Meditec, Inc.Costa Mesa, CA, United StatesSpecification developer0000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Auxein medical Private limitedSonipat Haryana, IndiaManufacturer0000api.fda.gov
B-One Medical (suzhou) Co., Ltd.Suzhou Jiangsu, ChinaContract manufacturer0000api.fda.gov
B-One Ortho, Corp.Cedar Knolls, NJ, United StatesManufacturer0000api.fda.gov
Biomet MicrofixationJacksonville, FL, United StatesManufacturer, Specification developer0000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer0000api.fda.gov
Corentec Co., Ltd.Cheonan Si, Chungnam, South KoreaExporter to the US, Manufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
In'tech Medical SASRANG DU FLIERS Pas-de-Calais, FranceContract manufacturer, Exporter to the US0000api.fda.gov
Instrumental Machine & Development, Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Instrumed International Inc dba Avalign German Specialty InstrumentsSchaumburg, IL, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Kaul Medizintechnik GMBHDierdorf Rhineland-Palatinate, GermanyManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesSpecification developer0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
Schobell Industrial LtdaRio Claro Sao Paulo, BrazilManufacturer0000api.fda.gov
Solco Biomedical Company India Private LimitedKADI Gujarat, IndiaContract manufacturer, Manufacturer0000api.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
Total Joint Orthopedics, Inc.Salt Lake City, UT, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
b-ONE Ortho Corp.Fairfield, NJ, United StatesSpecification developer0000api.fda.gov

Updated March 2, 1988. 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.