510(k) K011857 ยท HSB Rod, Fixation, Intramedullary And Accessories
SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM
| Applicant | Synthes (Usa), Paoli PA, US |
| Decision | Substantially Equivalent, Sep 12, 2001 |
| Received | Jun 14, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011857
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 21, 2017 | Synthes (USA) Products LLC 11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile Terminated |
HSB | None listed |
| Dec 4, 2015 | Synthes (USA) Products LLC Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA 420MM/Right Sterile (The TFN-ADVANCED Proximal Femoral Nailing System) The TFN-ADVANCED Proximal Femoral Nailing System is intende Terminated |
HSB | None listed |
| Nov 14, 2014 | Synthes, Inc. 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal femur Terminated |
HSB | None listed |
| Dec 10, 2013 | Synthes USA HQ, Inc. Synthes Trochanteric Fixation Nail
As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable and unstable fractures of the proximal femur. Terminated |
HSB | None listed |
| Dec 5, 2013 | Synthes USA HQ, Inc. Titanium Trochanteric Fixation Nail (TFN)System
Intended to treat stable and unstable fractures of the proximal femur. Terminated |
HSB | None listed |
| Nov 25, 2013 | Synthes USA HQ, Inc. Large Buttress Compression Nut For Blade Guide Sleeve TFN
The Synthes Large Buttress Compression Nut For Blade Guide Sleeve TFN is intended to treat stable and unstable pertrochanteric fractures, in Terminated |
HSB | None listed |
| Aug 26, 2013 | Synthes USA HQ, Inc. Synthes Trauma Nail System. The devices are indication for bone fixation. Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.