510(k) K152481 ยท GXQ Dura Substitute
DURAFORM Dural Graft Implant
| Applicant | Codman & Shurtleff, Inc., Raynham MA, US |
| Decision | Substantially Equivalent, Oct 30, 2015 |
| Received | Aug 31, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K152481
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2024 | Integra LifeSciences Corp. Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US
Lot CT007694 Open, Classified |
GXQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.