510(k) K092508 ยท GAT Suture, Nonabsorbable, Synthetic, Polyethylene
FAST-FIX 360 MENISCAL REPAIR SYSTEM, STRIAGHT, CURVED, REVERSE CURVED,FAST FIX 360 AB MENISCAL REPAIR SYSTEM, STRAIGHT,
| Applicant | Smith & Nephew, Inc., Andover MA, US |
| Decision | Substantially Equivalent, Jan 28, 2010 |
| Received | Aug 17, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092508
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2010 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew FAST FIX 360, STRAIGHT NEEDLE
Catalog Number; 72202467.
Intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as shoulder Terminated |
GAT | None listed |
| Nov 18, 2010 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew FAST FIX 360, CURVED NEEDLE
Catalog Number; 72202468.
Intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as shoulder st Terminated |
GAT | None listed |
| Nov 18, 2010 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew FAST FIX 360, REVERSE CURVED NEEDLE
Catalog Number; 72202469.
Intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as sho Terminated |
GAT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.