510(k) K122814 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
GALLEON PEDICLE SCREW SYSTEM
| Applicant | Everest Spine, LLC, Avon OH, US |
| Decision | Substantially Equivalent, Dec 3, 2012 |
| Received | Sep 13, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122814
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.