510(k) K180153 ยท NKB Thoracolumbosacral Pedicle Screw System
X-spine Cortical Bone Screw System
| Applicant | X-Spine Systems, Inc., Belgrade MT, US |
| Decision | Substantially Equivalent, Mar 15, 2018 |
| Received | Jan 19, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180153
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.