510(k) K133046 ยท KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
OMNIPORE CUSTOMIZED SURGICAL IMPLANTS
| Applicant | Matrix Surgical Holdings, LLC/Matrix Surgical USA, Alpharetta GA, US |
| Decision | Substantially Equivalent, May 14, 2014 |
| Received | Sep 27, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133046
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 28, 2017 | Matrix Surgical Holdings, LLC OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right Terminated |
KKY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.