510(k) K170763 ยท FTM Mesh, Surgical
Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend
| Applicant | Acell, Inc., Columbia MD, US |
| Decision | Substantially Equivalent, Jun 8, 2017 |
| Received | Mar 13, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170763
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 14, 2019 | ACell, Inc Gentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSMT3040, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended for implantation to reinforce soft tissue where weakness exists Terminated |
FTM | None listed |
| Feb 14, 2019 | ACell, Inc Gentrix Surgical Matrix Thick, 20 x 30cm, Catalog Number PSMT2030, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended for implantation to reinforce soft tissue where weakness exists Terminated |
FTM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.