510(k) K160640 ยท NKB Thoracolumbosacral Pedicle Screw System
PASS XS Spinal System
| Applicant | Medicrea International SA, Neyron, FR |
| Decision | Substantially Equivalent, Sep 23, 2016 |
| Received | Mar 7, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160640
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.