510(k) K180376 ยท NKB Thoracolumbosacral Pedicle Screw System
K2M Patient Specific Rods
| Applicant | K2m, Inc., Leesburg VA, US |
| Decision | Substantially Equivalent, Apr 5, 2018 |
| Received | Feb 12, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180376
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.