The following data is part of a premarket notification filed by Stryker with the FDA for Peek Customized Cranial Implant.
| Device ID | K153248 |
| 510k Number | K153248 |
| Device Name: | PEEK Customized Cranial Implant |
| Classification | Plate, Cranioplasty, Preformed, Alterable |
| 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 | GWO |
| CFR Regulation Number | 882.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-09 |
| Decision Date | 2016-03-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327300154 | K153248 | 000 |
| 07613327300048 | K153248 | 000 |
| 07613327300086 | K153248 | 000 |
| 07613327300109 | K153248 | 000 |
| 07613327300123 | K153248 | 000 |
| 07613327300017 | K153248 | 000 |
| 07613327300031 | K153248 | 000 |
| 07613327300055 | K153248 | 000 |
| 07613327300062 | K153248 | 000 |
| 07613327300079 | K153248 | 000 |
| 07613327300093 | K153248 | 000 |
| 07613327300116 | K153248 | 000 |
| 07613327300024 | K153248 | 000 |