K231208 is an FDA 510(k) clearance for the Stryker Resorbable Fixation System. This device is classified as a Fastener, Plate, Cranioplasty (Class II - Special Controls, product code HBW).
Submitted by Stryker Leibinger GmbH & Co KG (Freiburg, DE). The FDA issued a Cleared decision on August 14, 2023, 109 days after receiving the submission on April 27, 2023.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5360.
| 510(k) Number | K231208 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 2023 |
| Decision Date | August 14, 2023 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HBW — Fastener, Plate, Cranioplasty |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5360 |