510(k) K142052 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT
| Applicant | Orthofix Srl, Wilmington NC, US |
| Decision | Substantially Equivalent, Dec 5, 2014 |
| Received | Jul 28, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142052
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 5, 2017 | Orthofix Srl Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Galaxy UNYCO Diaphyseal Tibia Sterile Kit, Galaxy UNYCO Mini Kit Instruments Sterile, Galaxy UNYCO Diaph Terminated |
KTT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.