510(k) K103010 ยท KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
STRYKER PATIENT SPECIFIC POLYMER IMPLANT
| Applicant | Howmedica Osteonics Corp., Dba Stryker Orthopaedics, Mahwah NJ, US |
| Decision | Substantially Equivalent, Oct 26, 2010 |
| Received | Oct 12, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K103010
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 12, 2014 | Stryker Howmedica Osteonics Corp. Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2)
5444-01-102 Host Bone; Howmedica Osteonics Corp.
325 Corporate Drive, Mahwah, NJ 07430 USA.
Designed individually for each Terminated |
KKY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.