K121315 is an FDA 510(k) clearance for the STRYKER CMF MEDPOR CUSTOMIZED IMPLANT. This device is classified as a Prosthesis, Chin, Internal (Class II - Special Controls, product code FWP).
Submitted by Howmedica Osteonics Corp. (Newnan, US). The FDA issued a Cleared decision on November 1, 2012, 183 days after receiving the submission on May 2, 2012.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3550.
| 510(k) Number | K121315 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 2012 |
| Decision Date | November 01, 2012 |
| Days to Decision | 183 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FWP — Prosthesis, Chin, Internal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3550 |