510(k) K121115 ยท KWP Appliance, Fixation, Spinal Interlaminal
M.U.S.T PEDICLE SCREW SYSTEM
| Applicant | Medacta International, Camarillo CA, US |
| Decision | Substantially Equivalent, Jul 18, 2012 |
| Received | Apr 12, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121115
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 13, 2017 | Medacta Usa Inc Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480mm, Type Straight, Mat Co-Cr-Mo
The rods act as a connector between the different pedicle screws to create a stable cons Terminated |
KWP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.