The following data is part of a premarket notification filed by Stryker with the FDA for Stryker Peek Customized Cranial Implant Kit.
| Device ID | K190229 |
| 510k Number | K190229 |
| Device Name: | Stryker PEEK Customized Cranial Implant Kit |
| Classification | Plate, Cranioplasty, Preformed, Alterable |
| Applicant | Stryker 750 Trade Centre Way - Suite 200 Portage, MI 49002 |
| Contact | Zainab Amini |
| Correspondent | Zainab Amini 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 | 2019-02-05 |
| Decision Date | 2019-07-11 |