510(k) K132079 ยท GAT Suture, Nonabsorbable, Synthetic, Polyethylene
TFCC FAST-FIX KIT
| Applicant | Smith & Nephew, Inc., Andover MA, US |
| Decision | Substantially Equivalent, Dec 5, 2013 |
| Received | Jul 5, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132079
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 22, 2015 | Smith & Nephew, Inc. ULTRA-FAST FIX Knot Pusher Suture Cutters
Product Number: 72201537
Intended for Meniscal Repair. Terminated |
GAT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.