510(k) K023941 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
SYNTHES TOMOFIX OSTEOTOMY SYSTEM
| Applicant | Synthes (Usa), Paoli PA, US |
| Decision | Substantially Equivalent, Jan 23, 2003 |
| Received | Nov 26, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023941
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 10, 2013 | Synthes USA HQ, Inc. Synthes TomoFix Plates
The Synthes J5606-C TomoFix Osteotomy System is used for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia, medial and lateral distal femur Terminated |
KTT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.