The following data is part of a premarket notification filed by Stryker with the FDA for Peek Customized Cranial Implant, Peek Customized Cranial Implant Priority.
| Device ID | K152076 |
| 510k Number | K152076 |
| Device Name: | PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-27 |
| Decision Date | 2015-08-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327129335 | K152076 | 000 |
| 07613327300048 | K152076 | 000 |
| 07613327300123 | K152076 | 000 |
| 07613327300031 | K152076 | 000 |
| 07613327300055 | K152076 | 000 |
| 07613327300079 | K152076 | 000 |
| 07613327300086 | K152076 | 000 |
| 07613327300109 | K152076 | 000 |
| 07613327129236 | K152076 | 000 |
| 07613327129243 | K152076 | 000 |
| 07613327129250 | K152076 | 000 |
| 07613327129267 | K152076 | 000 |
| 07613327129274 | K152076 | 000 |
| 07613327129281 | K152076 | 000 |
| 07613327129298 | K152076 | 000 |
| 07613327129304 | K152076 | 000 |
| 07613327129328 | K152076 | 000 |
| 07613327300017 | K152076 | 000 |