K212943 is an FDA 510(k) clearance for the SyntheCel Dura Repair. This device is classified as a Dura Substitute (Class II - Special Controls, product code GXQ).
Submitted by Synthes USA Products, LLC (West Chester, US). The FDA issued a Cleared decision on January 28, 2022, 135 days after receiving the submission on September 15, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5910.
| 510(k) Number | K212943 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 15, 2021 |
| Decision Date | January 28, 2022 |
| Days to Decision | 135 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXQ — Dura Substitute |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5910 |