510(k) K111323 ยท KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS
| Applicant | Synthes, Inc., West Chester PA, US |
| Decision | Substantially Equivalent, Nov 16, 2011 |
| Received | May 11, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111323
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.