510(k) K111025 ยท HSB Rod, Fixation, Intramedullary And Accessories
TRIGEN LOW PROFILE BONE SCREW
| Applicant | Smith & Nephew, Inc., Cordova TN, US |
| Decision | Substantially Equivalent, Jul 1, 2011 |
| Received | Apr 13, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111025
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 17, 2013 | Smith & Nephew Inc TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN 38116 USA
orthopedic surgery Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.