510(k) K091976 ยท HSB Rod, Fixation, Intramedullary And Accessories
BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL
| Applicant | Biomet Trauma, Parsippany NJ, US |
| Decision | Substantially Equivalent, Aug 17, 2009 |
| Received | Jul 1, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091976
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 27, 2018 | Zimmer Biomet, Inc. Phoenix Nail System, intended for use with an intramedullary nail system for alignment, stabilization and fixation of fractures. 3.5mm Inserter Connector, Short; Model Number: 14-441045; Kit Model Num Terminated |
HSB | 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.