510(k) K210980 ยท HSB Rod, Fixation, Intramedullary And Accessories
Smith & Nephew Intramedullary Nail Systems
| Applicant | Smith & Nephew, Inc., Cordova TN, US |
| Decision | Substantially Equivalent, Nov 14, 2022 |
| Received | Apr 1, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210980
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 16, 2026 | Smith & Nephew, Inc. TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816 Open, Classified |
HSB | None listed |
| May 19, 2025 | Smith & Nephew, Inc. META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690 Open, Classified |
HSB | None listed |
| Aug 22, 2023 | Smith & Nephew, Inc. TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail Open, Classified |
HSB | None listed |
| Aug 22, 2023 | Smith & Nephew, Inc. TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail Open, Classified |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.