The following data is part of a premarket notification filed by Stryker with the FDA for Stryker Cmf Medpor Customized Implant.
| Device ID | K143173 |
| 510k Number | K143173 |
| Device Name: | Stryker CMF MEDPOR Customized Implant |
| Classification | Prosthesis, Chin, Internal |
| Applicant | Stryker 750 Trade Centre Way - Suite 200 Portage, MI 49002 |
| Contact | Julie Schoell |
| Correspondent | Julie Schoell Stryker 750 Trade Centre Way - Suite 200 Portage, MI 49002 |
| Product Code | FWP |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-04 |
| Decision Date | 2015-03-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327480245 | K143173 | 000 |
| 07613252457671 | K143173 | 000 |
| 07613252457664 | K143173 | 000 |
| 07613252457657 | K143173 | 000 |
| 07613252457640 | K143173 | 000 |
| 07613252457633 | K143173 | 000 |
| 07613252457626 | K143173 | 000 |