Submission Details
| 510(k) Number | K212943 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
SyntheCel Dura Repair
Jan 2022
Decision
135d
Days
Class 2
Risk
About This 510(k) Submission
K212943 is an FDA 510(k) clearance for the SyntheCel Dura Repair, 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 review panel. Regulated under 21 CFR 882.5910.
Device Classification
| Product Code | GXQ — Dura Substitute |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 882.5910 |
Manufacturer
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