510(k) K043052 ยท HSB Rod, Fixation, Intramedullary And Accessories
TRIGEN HINDFOOT FUSION NAIL
| Applicant | Smith & Nephew, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Nov 24, 2004 |
| Received | Nov 5, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K043052
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2008 | Smith & Nephew Inc TRIGEN Hind Foot Fusion Nail, 10mm X 25mm Left, REF 71701025L. The device is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot. Terminated |
HSB | None listed |
| Sep 16, 2008 | Smith & Nephew Inc TRIGEN Hind Foot Fusion Nail, 11.5mm X 25mm Left, REF 71701125L. The device is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot. Terminated |
HSB | None listed |
| Sep 16, 2008 | Smith & Nephew Inc TRIGEN Hind Foot Fusion Nail, 11.5mm X 20mm Left, REF 71701120L. The device is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot. Terminated |
HSB | None listed |
| Sep 16, 2008 | Smith & Nephew Inc TRIGEN Hind Foot Fusion Nail, 10mm X 20mm Left, REF 71701020L. The device is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot. Terminated |
HSB | None listed |
| Sep 16, 2008 | Smith & Nephew Inc TRIGEN Hind Foot Fusion Nail, 10mm X 16mm Left, REF 71701016L. The device is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot. Terminated |
HSB | None listed |
| Sep 16, 2008 | Smith & Nephew Inc TRIGEN Hind Foot Fusion Nail, 11.5mm X 20mm Right, REF 71701120R. The device is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot Terminated |
HSB | None listed |
| Sep 16, 2008 | Smith & Nephew Inc TRIGEN Hind Foot Fusion Nail, 11.5mm X 25mm Right, REF 71701125R. The device is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.