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Data / Medical devices / Screwdriver, Surgical

Screwdriver, Surgical (LRZ): 25 FDA-registered makers in 7 countries

25 establishments in 7 countries are registered with the FDA to make Screwdriver, Surgical (product code LRZ, Class 1, 21 CFR 878.4800). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on December 27, 1989, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
LRZ
Device class
1
Regulation
878.4800
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
United States8
Germany6
Pakistan5
South Korea3
France1
China1
Malaysia1

Makers of Screwdriver, Surgical

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
Asanus Medizintechnik GMBHNEUHAUSEN OBECK Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Askorn MedicalCesson Sevigne Bretagne, FranceExporter to the US, Specification developer0000api.fda.gov
Apex (Guangzhou) Tools & Orthopedics CompanyGuangzhou Guangdong, ChinaContract manufacturer0000api.fda.gov
BIEDERMANN MOTECH GMBH & Co. KGVS-SCHWENNINGEN Baden-Wurttemberg, GermanyManufacturer, Specification developer0000api.fda.gov
Bioplate, Inc.Placentia, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Blache Medical GMBH & Co. KGWellendingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Berger Surgical Medical Products GmbHNeuhausen ob Eck Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Comfort Surgical InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Cowellmedi Co., Ltd.Busan, South KoreaManufacturer0000api.fda.gov
ClearPoint Neuro Inc.Carlsbad, CA, United StatesManufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Geister Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
High-Tech Quality MFG. Inc.Salt Lake City, UT, United StatesContract manufacturer0000api.fda.gov
Hive International Pvt Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Integrated Orbital Implants, Inc.San Diego, CA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
MEDIKAN CO., Ltd.Gangseo-gu Seoul, South KoreaManufacturer0000api.fda.gov
Nextcon InternationalSialkot Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Ortho Solutions Sdn BhdPrai, Penang Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
RSB Spine LLC.Wooster, OH, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Surgicon Pvt LtdSialkot Punjab, PakistanManufacturer0000api.fda.gov
TDM Co.,ltdBuk-gu Gwangju, South KoreaManufacturer0000api.fda.gov
Triangle Manufacturing Co., Inc.Upper Saddle River, NJ, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Tyber MedicalBethlehem, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
Tyber MedicalBethlehem, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
Ustomed Instrumente GMBH & Co. KGTuttlingen Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov

Updated December 27, 1989. 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.