Data / Medical devices / Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction / United States
FDA-registered makers of Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction in the United States: 9 establishments
9 establishments in the United States are registered with the FDA to make Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction (product code KKY). 8 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 3, 2026.
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- Device
- Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
- Product code
- KKY
- Country
- United States
Makers of Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| MATRIX SURGICAL HOLDINGS, LLC dba MATRIX SURGICAL USA | Newnan, GA, United States | Manufacturer | 2 | May 14, 2014 | 0 | 2 | 0 | api.fda.gov |
| Synthes (USA) Products LLC | West Chester, PA, United States | Complaint file establishment, Specification developer | 2 | November 16, 2011 | 0 | 0 | 0 | api.fda.gov |
| Biomet Microfixation | Jacksonville, FL, United States | Manufacturer | 1 | September 2, 1993 | 0 | 1 | 0 | api.fda.gov |
| Howmedica Osteonics Corp | Mahwah, NJ, United States | Manufacturer | 1 | October 26, 2010 | 0 | 1 | 0 | api.fda.gov |
| Longeviti Neuro Solutions | Baltimore, MD, United States | Specification developer | 1 | July 15, 2021 | 0 | 0 | 0 | api.fda.gov |
| Oxford Performance Materials, Inc. | South Windsor, CT, United States | Complaint file establishment, Manufacturer | 1 | July 20, 2016 | 0 | 0 | 0 | api.fda.gov |
| Poriferous, LLC | Newnan, GA, United States | Manufacturer | 1 | June 13, 2014 | 0 | 0 | 0 | api.fda.gov |
| Surgical Technology Laboratories Inc. | Lugoff, SC, United States | Manufacturer | 1 | October 16, 2002 | 0 | 0 | 0 | api.fda.gov |
| Implantech Associates, Inc. | Ventura, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.