The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Stryker Cmf Medpor Customized Implant.
| Device ID | K121315 |
| 510k Number | K121315 |
| Device Name: | STRYKER CMF MEDPOR CUSTOMIZED IMPLANT |
| Classification | Prosthesis, Chin, Internal |
| Applicant | HOWMEDICA OSTEONICS CORP. 15 Dart Rd Newnan, GA 30265 |
| Contact | Stephanie Fullard |
| Correspondent | Stephanie Fullard HOWMEDICA OSTEONICS CORP. 15 Dart Rd Newnan, GA 30265 |
| Product Code | FWP |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-02 |
| Decision Date | 2012-11-01 |
| Summary: | summary |