510(k) K161370 ยท GXQ Dura Substitute
Durepair Dura Regeneration Matrix
| Applicant | Medtronic Neurosurgery, Goleta CA, US |
| Decision | Substantially Equivalent, Nov 2, 2016 |
| Received | May 17, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161370
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2023 | Medtronic Neurosurgery Durepair Dura Regeneration Matrix:
DUREPAIR DURA SUBSTITUTE 2 X 2, 61100;
DUREPAIR DURA SUBSTITUTE 3 X 3, 61105;
DUREPAIR DURA SUBSTITUTE 1 X 3, 61106;
DUREPAIR DURA SUBSTITUTE 4 X 5, 61110;
DUREPAIR Open, Classified |
GXQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.