510(k) K101278 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
INERTIA PEDICLE SCREW SYSTEM
| Applicant | Nexxt Spine, LLC, Chesterland OH, US |
| Decision | Substantially Equivalent, Dec 20, 2010 |
| Received | May 6, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101278
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.