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
| Country | Makers |
|---|---|
| United States | 36 |
| Germany | 9 |
| Switzerland | 3 |
| Japan | 1 |
| Mexico | 1 |
| Pakistan | 1 |
| Hungary | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Depuy Spine, Inc. | Raynham, MA, United States | Specification developer | 4 | January 27, 2012 | 0 | 0 | 0 | api.fda.gov |
| STERIS Corporation | Saint Louis, MO, United States | Manufacturer, Repackager or relabeler, Specification developer | 4 | March 18, 2009 | 0 | 0 | 0 | api.fda.gov |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Specification developer | 3 | September 9, 2016 | 0 | 0 | 0 | api.fda.gov |
| Medos International Sarl | Le Locle Neuchatel, Switzerland | Specification developer | 3 | December 16, 2011 | 0 | 0 | 0 | api.fda.gov |
| Vycor Medical Inc | Boca Raton, FL, United States | Complaint file establishment, Specification developer | 2 | January 14, 2021 | 0 | 1 | 1 | api.fda.gov |
| AVALIGN TECHNOLOGIES, Inc. | Fort Wayne, IN, United States | Specification developer | 1 | August 2, 2007 | 0 | 0 | 0 | api.fda.gov |
| COMPASS International Innovations, Inc. | Rochester, MN, United States | Manufacturer, Specification developer | 1 | December 6, 1989 | 0 | 0 | 0 | api.fda.gov |
| Fetzer Surgical, LLC | Scottsdale, AZ, United States | Repackager or relabeler, Specification developer | 1 | September 9, 2016 | 0 | 0 | 0 | api.fda.gov |
| Geister Medizintechnik GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 1 | August 29, 2018 | 0 | 0 | 0 | api.fda.gov |
| Integra Lifesciences Corporation | Cincinnati, OH, United States | Manufacturer | 1 | March 2, 1983 | 0 | 0 | 0 | api.fda.gov |
| Instrumed International Inc dba Avalign German Specialty Instruments | Schaumburg, IL, United States | Contract manufacturer, Repackager or relabeler | 1 | August 2, 2007 | 0 | 0 | 0 | api.fda.gov |
| Medicon, E.G. | TUTTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 1 | March 24, 2017 | 0 | 0 | 0 | api.fda.gov |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 1 | August 2, 2007 | 0 | 0 | 0 | api.fda.gov |
| MIZUHO Corporation Gosen Factory | Gosen Niigata, Japan | Manufacturer | 1 | July 3, 1990 | 0 | 0 | 0 | api.fda.gov |
| Nico Corporation | Indianapolis, IN, United States | Specification developer | 1 | September 7, 2017 | 0 | 2 | 0 | api.fda.gov |
| Pharaoh Neuro, Inc. | Minneapolis, MN, United States | Specification developer | 1 | August 26, 2020 | 0 | 0 | 0 | api.fda.gov |
| Surgentec LLC | Boca Raton, FL, United States | Manufacturer | 1 | September 17, 2026 | 0 | 0 | 0 | api.fda.gov |
| Synthes GMBH | Selzach Solothurn, Switzerland | Manufacturer | 1 | December 15, 2006 | 0 | 0 | 0 | api.fda.gov |
| Tedan Surgical Innovations, Inc. | Sugar Land, TX, United States | Repackager or relabeler, Specification developer | 1 | March 20, 2017 | 0 | 0 | 0 | api.fda.gov |
| Thompson Surgical Instruments, Inc. | Traverse City, MI, United States | Manufacturer | 1 | May 13, 2022 | 0 | 0 | 0 | api.fda.gov |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 1 | August 2, 2007 | 0 | 0 | 0 | api.fda.gov |
| Aesculap AG | TUTTLINGEN, DONAU Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Seabrook | Seabrook, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| August Reuchlen GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Autocam Medical | Plymouth, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Autocam Medical | Murfreesboro, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avalign Delivery Systems Division | Greenwood, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fetzer Medical GMBH & Co.kg | Tuttlingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Five Star Manufacturing, Inc. | New Bedford, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flexbar Machine Corp. | Islandia, NY, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gmi Corporation | Franklin, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebumedical GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industrias Apson S.A de C.V | AGUA PRIETA Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Switzerland Manufacturing GmbH (Le Locle) | Le Locle Neuchatel, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kreidler Medizintechnik GmbH | Wurmlingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Life Science Outsourcing, Inc. | Brea, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Max Hauser Suddeutsche Chirurgiemechanik GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micropulse Inc | Columbia City, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Minnetronix, Inc. | Saint Paul, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Metal Craft Machine & Engineering, Inc. | Elk River, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical, Inc. | Pierceton, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phoenix Instruments, Inc. | Lisle, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision Optics Corp. | Gardner, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primo Medical Group, Inc | W Bridgewater, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qsa Surgical (pvt) Ltd. | SIALKOT Punjab, Pakistan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rebound Therapeutics, Corporation | Irvine, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Riverside Machine & Engineering, Inc. | Eau Claire, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RMS Co. | Minneapolis, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rudolf Storz GMBH | EMMINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SUBAN Instruments Hungary Co. | DEBRECEN Hajdu-Bihar, Hungary | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tech Industries. Inc. | Cleveland, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viant AS&O Holdings, LLC | Brimfield, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.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.