510(k) K180301 ยท NKB Thoracolumbosacral Pedicle Screw System
AXIS 5.5 Lumbar Pedicle Screw System
| Applicant | Axis Orthopaedics, Soldotna AK, US |
| Decision | Substantially Equivalent, Apr 10, 2018 |
| Received | Feb 2, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180301
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.