Data / Medical devices / Cover, Burr Hole / United States
FDA-registered makers of Cover, Burr Hole in the United States: 20 establishments
20 establishments in the United States are registered with the FDA to make Cover, Burr Hole (product code GXR). 7 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Cover, Burr Hole
- Product code
- GXR
- Country
- United States
Makers of Cover, Burr Hole in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Synthes (USA) Products LLC | West Chester, PA, United States | Complaint file establishment, Specification developer | 5 | August 16, 2013 | 0 | 0 | 0 | api.fda.gov |
| Abbott Medical | Plano, TX, United States | Manufacturer | 2 | July 20, 2018 | 0 | 0 | 0 | api.fda.gov |
| Abyrx, Inc. | Stamford, CT, United States | Complaint file establishment, Manufacturer | 1 | March 16, 2026 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Neuromodulation | Minneapolis, MN, United States | Manufacturer | 1 | October 25, 2000 | 0 | 1 | 0 | api.fda.gov |
| Medtronic Neurosurgery | Fort Worth, TX, United States | Specification developer | 1 | May 7, 2001 | 0 | 0 | 0 | api.fda.gov |
| Neuropace | Mountain View, CA, United States | Manufacturer | 1 | July 11, 2014 | 0 | 0 | 0 | api.fda.gov |
| Neurovention, LLC | Daytona Beach, FL, United States | Specification developer | 1 | March 13, 2020 | 0 | 0 | 0 | api.fda.gov |
| Biomet Microfixation | Jacksonville, FL, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomet, Inc. | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioplate, Inc. | Placentia, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| INNO Holdings Inc. | Millcreek, UT, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. (Elmira) | Horseheads, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. (Monument) | Monument, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kinamed, Inc. | Camarillo, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mci Medical Concept Innovation Inc. | Sunrise, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osteomed | Addison, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pro-Tech Design & MFG., Inc. | Santa Fe Springs, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Tech Services, LLC | Bloomington, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tecomet | Woburn, MA, 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 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.