The following data is part of a premarket notification filed by Stryker with the FDA for Peek Customized Craial Implant Kit.
| Device ID | K121153 |
| 510k Number | K121153 |
| Device Name: | PEEK CUSTOMIZED CRAIAL IMPLANT KIT |
| Classification | Plate, Cranioplasty, Preformed, Alterable |
| Applicant | Stryker 750 TRADE CENTRE WAY STE 200 Portage, MI 49002 |
| Contact | Manish Patel |
| Correspondent | Manish Patel Stryker 750 TRADE CENTRE WAY STE 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 | 2012-04-16 |
| Decision Date | 2012-09-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327004021 | K121153 | 000 |
| 04546540730800 | K121153 | 000 |
| 04546540730794 | K121153 | 000 |
| 04546540730787 | K121153 | 000 |
| 04546540730763 | K121153 | 000 |