Data / Medical devices / Methyl Methacrylate For Cranioplasty / United States
FDA-registered makers of Methyl Methacrylate For Cranioplasty in the United States: 15 establishments
15 establishments in the United States are registered with the FDA to make Methyl Methacrylate For Cranioplasty (product code GXP). 4 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Methyl Methacrylate For Cranioplasty
- Product code
- GXP
- Country
- United States
Makers of Methyl Methacrylate For Cranioplasty in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Abyrx, Inc. | Stamford, CT, United States | Complaint file establishment, Manufacturer | 7 | June 15, 2026 | 0 | 0 | 0 | api.fda.gov |
| Synthes (USA) Products LLC | West Chester, PA, United States | Complaint file establishment, Specification developer | 3 | September 23, 2010 | 0 | 0 | 0 | api.fda.gov |
| Biomet Microfixation | Jacksonville, FL, United States | Complaint file establishment, Specification developer | 2 | December 4, 2002 | 0 | 0 | 0 | api.fda.gov |
| Dimensional Bioceramics, LLC | Scotts Valley, CA, United States | Specification developer | 1 | June 20, 2019 | 0 | 0 | 0 | api.fda.gov |
| Biomet, Inc. | Warsaw, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Berkeley Advanced Biomaterials | Berkeley, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Highridge Medical, LLC | Westminster, CO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KLS Martin Manufacturing, LLC | Jacksonville, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KLS-Martin L.P. | Jacksonville, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics | Olyphant, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics | Edison, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics | Jessup, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Natus Neurology Incorporated | Middleton, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Olive Branch Distribution Center | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PDV MedTech | Morgan Hill, CA, 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.