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Data / Medical devices / Retractor, Self-Retaining, For Neurosurgery

Retractor, Self-Retaining, For Neurosurgery (GZT): 52 FDA-registered makers in 7 countries

52 establishments in 7 countries are registered with the FDA to make Retractor, Self-Retaining, For Neurosurgery (product code GZT, Class 2, 21 CFR 882.4800). 21 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 44 510(k) clearances under this code, the latest on September 17, 2026, and lists 5 recall events (1 Class I). FDA data exported November 2, 2026.

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Product code
GZT
Device class
2
Regulation
882.4800
Medical specialty
Neurology

Makers by country

CountryMakers
United States36
Germany9
Switzerland3
Japan1
Mexico1
Pakistan1
Hungary1

Makers of Retractor, Self-Retaining, For Neurosurgery

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
Depuy Spine, Inc.Raynham, MA, United StatesSpecification developer4January 27, 2012000api.fda.gov
STERIS CorporationSaint Louis, MO, United StatesManufacturer, Repackager or relabeler, Specification developer4March 18, 2009000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer3September 9, 2016000api.fda.gov
Medos International SarlLe Locle Neuchatel, SwitzerlandSpecification developer3December 16, 2011000api.fda.gov
Vycor Medical IncBoca Raton, FL, United StatesComplaint file establishment, Specification developer2January 14, 2021011api.fda.gov
AVALIGN TECHNOLOGIES, Inc.Fort Wayne, IN, United StatesSpecification developer1August 2, 2007000api.fda.gov
COMPASS International Innovations, Inc.Rochester, MN, United StatesManufacturer, Specification developer1December 6, 1989000api.fda.gov
Fetzer Surgical, LLCScottsdale, AZ, United StatesRepackager or relabeler, Specification developer1September 9, 2016000api.fda.gov
Geister Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer1August 29, 2018000api.fda.gov
Integra Lifesciences CorporationCincinnati, OH, United StatesManufacturer1March 2, 1983000api.fda.gov
Instrumed International Inc dba Avalign German Specialty InstrumentsSchaumburg, IL, United StatesContract manufacturer, Repackager or relabeler1August 2, 2007000api.fda.gov
Medicon, E.G.TUTTLINGEN Baden-Wurttemberg, GermanyManufacturer1March 24, 2017000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer1August 2, 2007000api.fda.gov
MIZUHO Corporation Gosen FactoryGosen Niigata, JapanManufacturer1July 3, 1990000api.fda.gov
Nico CorporationIndianapolis, IN, United StatesSpecification developer1September 7, 2017020api.fda.gov
Pharaoh Neuro, Inc.Minneapolis, MN, United StatesSpecification developer1August 26, 2020000api.fda.gov
Surgentec LLCBoca Raton, FL, United StatesManufacturer1September 17, 2026000api.fda.gov
Synthes GMBHSelzach Solothurn, SwitzerlandManufacturer1December 15, 2006000api.fda.gov
Tedan Surgical Innovations, Inc.Sugar Land, TX, United StatesRepackager or relabeler, Specification developer1March 20, 2017000api.fda.gov
Thompson Surgical Instruments, Inc.Traverse City, MI, United StatesManufacturer1May 13, 2022000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler1August 2, 2007000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyComplaint file establishment, Manufacturer0000api.fda.gov
ARCH Medical Solutions - SeabrookSeabrook, NH, United StatesContract manufacturer0000api.fda.gov
August Reuchlen GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Autocam MedicalPlymouth, MA, United StatesContract manufacturer0000api.fda.gov
Autocam MedicalMurfreesboro, TN, United StatesContract manufacturer0000api.fda.gov
Avalign Delivery Systems DivisionGreenwood, IN, United StatesContract manufacturer0000api.fda.gov
Fetzer Medical GMBH & Co.kgTuttlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Five Star Manufacturing, Inc.New Bedford, MA, United StatesContract manufacturer0000api.fda.gov
Flexbar Machine Corp.Islandia, NY, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Gmi CorporationFranklin, IN, United StatesContract manufacturer0000api.fda.gov
Hebumedical GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Jabil Switzerland Manufacturing GmbH (Le Locle)Le Locle Neuchatel, SwitzerlandContract manufacturer0000api.fda.gov
Kreidler Medizintechnik GmbHWurmlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Life Science Outsourcing, Inc.Brea, CA, United StatesContract manufacturer0000api.fda.gov
Max Hauser Suddeutsche Chirurgiemechanik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Micropulse IncColumbia City, IN, United StatesContract manufacturer0000api.fda.gov
Minnetronix, Inc.Saint Paul, MN, United StatesContract manufacturer0000api.fda.gov
Metal Craft Machine & Engineering, Inc.Elk River, MN, United StatesContract manufacturer0000api.fda.gov
Paragon Medical, Inc.Pierceton, IN, United StatesContract manufacturer0000api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
Precision Optics Corp.Gardner, MA, United StatesContract manufacturer0000api.fda.gov
Primo Medical Group, IncW Bridgewater, MA, United StatesContract manufacturer0000api.fda.gov
Qsa Surgical (pvt) Ltd.SIALKOT Punjab, PakistanContract manufacturer0000api.fda.gov
Rebound Therapeutics, CorporationIrvine, CA, United StatesManufacturer0000api.fda.gov
Riverside Machine & Engineering, Inc.Eau Claire, WI, United StatesContract manufacturer0000api.fda.gov
RMS Co.Minneapolis, MN, United StatesContract manufacturer0000api.fda.gov
Rudolf Storz GMBHEMMINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
SUBAN Instruments Hungary Co.DEBRECEN Hajdu-Bihar, HungaryContract manufacturer0000api.fda.gov
Tech Industries. Inc.Cleveland, OH, United StatesContract manufacturer0000api.fda.gov
Viant AS&O Holdings, LLCBrimfield, MA, United StatesContract manufacturer0000api.fda.gov

Updated September 17, 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.