Data / Medical devices / Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction (KKY): 9 FDA-registered makers in 1 country
9 establishments in 1 country are registered with the FDA to make Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction (product code KKY, Class 2, 21 CFR 878.3500). 8 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 25 510(k) clearances under this code, the latest on July 15, 2021, and lists 5 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KKY
- Device class
- 2
- Regulation
- 878.3500
- Medical specialty
- General, Plastic Surgery
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
Makers of Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
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 |
|---|---|---|---|---|---|---|---|---|
| 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 July 15, 2021. 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.