K153248 is an FDA 510(k) clearance for the PEEK Customized Cranial Implant. This device is classified as a Plate, Cranioplasty, Preformed, Alterable (Class II - Special Controls, product code GWO).
Submitted by Stryker (Portage, US). The FDA issued a Cleared decision on March 10, 2016, 122 days after receiving the submission on November 9, 2015.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5320.
| 510(k) Number | K153248 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 2015 |
| Decision Date | March 10, 2016 |
| Days to Decision | 122 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GWO — Plate, Cranioplasty, Preformed, Alterable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5320 |