510(k) K181633 ยท GAT Suture, Nonabsorbable, Synthetic, Polyethylene
MTF Pre-Sutured Tendon
| Applicant | Musculoskeletal Transplant Foundation, Edison NJ, US |
| Decision | Substantially Equivalent, Mar 15, 2019 |
| Received | Jun 20, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181633
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 15, 2019 | Musculoskeletal Transplant Foundation, Inc. QuickGraft
Model # 430PST Terminated |
GAT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.