510(k) K180980 · NKB Thoracolumbosacral Pedicle Screw System
ORTHROS Posterior Stabilization System; ORTHROS MIS Posterior Stabilization System
| Applicant | Camber Spine Technologies, LLC, Wayne PA, US |
| Decision | Substantially Equivalent, Oct 27, 2018 |
| Received | Apr 13, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180980
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.