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

FDA-registered makers of Retractor, Self-Retaining, For Neurosurgery in the United States: 36 establishments

36 establishments in the United States are registered with the FDA to make Retractor, Self-Retaining, For Neurosurgery (product code GZT). 16 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.

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Device
Retractor, Self-Retaining, For Neurosurgery
Product code
GZT
Country
United States

Makers of Retractor, Self-Retaining, For Neurosurgery in the United States

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
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
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
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer1August 2, 2007000api.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
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
ARCH Medical Solutions - SeabrookSeabrook, NH, United StatesContract 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
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
Life Science Outsourcing, Inc.Brea, CA, United StatesContract 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
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
Tech Industries. Inc.Cleveland, OH, United StatesContract manufacturer0000api.fda.gov
Viant AS&O Holdings, LLCBrimfield, MA, United StatesContract manufacturer0000api.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.