510(k) K153233 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Galaxy UNYCO System
| Applicant | Orthofix Srl, Bussolengo, IT |
| Decision | Substantially Equivalent, Jan 6, 2016 |
| Received | Nov 9, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153233
| 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.