The following data is part of a premarket notification filed by Stryker with the FDA for Stryker Cmf Medpor Customized Implant.
| Device ID | K153508 |
| 510k Number | K153508 |
| Device Name: | Stryker CMF MEDPOR Customized Implant |
| Classification | Prosthesis, Chin, Internal |
| Applicant | Stryker 750 Trade Centre Way, Suite 200 Portage, MI 49002 |
| Contact | Jonathan Schell |
| Correspondent | Jonathan Schell 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 | 2015-12-07 |
| Decision Date | 2016-02-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327300482 | K153508 | 000 |
| 07613327300468 | K153508 | 000 |
| 07613327300420 | K153508 | 000 |
| 07613327300390 | K153508 | 000 |
| 07613327300543 | K153508 | 000 |