510(k) K063570 ยท HSB Rod, Fixation, Intramedullary And Accessories
BIOMET TIBIAL LOCKING NAIL SYSTEM
| Applicant | Biomet Manufacturing Corp, Warsaw IN, US |
| Decision | Substantially Equivalent, Feb 27, 2007 |
| Received | Nov 29, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063570
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2020 | Biomet, Inc. PHOENIX, Interlocking screw for IM nail, Item numbers 14-405040, 14-405042, 14-405044, 14-405070 - Product Usage: Fracture fixation of small bones, small bone fragements and long bones. Terminated |
HSB | None listed |
| Dec 17, 2020 | Biomet, Inc. RINGLOC ACETABULAR SYSTEM Self-tapping bone screws, Item numbers 103531, 103533, 103534, 103535 - Product Usage: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Hip, Semi-Const Terminated |
LPH | None listed |
| May 26, 2016 | Biomet, Inc. Various trauma and sports medicine instruments and implants.
Rod, fixation, intramedullary and accessories. Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.