510(k) K212943 ยท GXQ Dura Substitute
SyntheCel Dura Repair
| Applicant | Synthes (USA) Products, LLC, West Chester PA, US |
| Decision | Substantially Equivalent, Jan 28, 2022 |
| Received | Sep 15, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212943
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.