510(k) K951626 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
SYNTHES (U.S.A.) UNIVERSAL SPINAL HOOK, ROD AND PEDICLE/SACRAL SCREW FIXATION SYSTEM
| Applicant | Synthes (Usa), Paoli PA, US |
| Decision | Substantially Equivalent for Some Indications, Aug 21, 1995 |
| Received | Apr 7, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951626
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.