510(k) K131548 ยท HSB Rod, Fixation, Intramedullary And Accessories
SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEM
| Applicant | Synthes (USA) Products, LLC, West Chester PA, US |
| Decision | Substantially Equivalent, Feb 28, 2014 |
| Received | May 30, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131548
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 1, 2024 | Synthes (USA) Products LLC TFNA Femoral Nail 9mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures.
Part Number: 04.037.944S Open, Classified |
HSB | None listed |
| Mar 1, 2024 | Synthes (USA) Products LLC TFNA Femoral Nail 11mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures.
Part Number: 04.037.144S Open, Classified |
HSB | None listed |
| Mar 10, 2023 | Synthes (USA) Products LLC TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures.
Part Number: 04.037.213S Open, Classified |
HSB | None listed |
| Mar 10, 2023 | Synthes (USA) Products LLC TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixation and stabilization of proximal femur fractures.
Part Number: 04.037.212S Open, Classified |
HSB | None listed |
| Mar 10, 2023 | Synthes (USA) Products LLC TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures
Part Number: 04.037.242S Open, Classified |
HSB | None listed |
| Oct 15, 2015 | Synthes (USA) Products LLC Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent disengagement during head element insertion. Terminated |
HSB | None listed |
| Jul 16, 2015 | Synthes (USA) Products LLC Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent disengagement during head element insertion. Manual Terminated |
HSB | None listed |
| May 12, 2015 | Synthes, Inc. TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma. Terminated |
HSB | None listed |
| Mar 30, 2015 | Synthes, Inc. Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing Sy Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.