510(k) K963357 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK, ROD, AND AND SACRAL SCREW FIXATION SYSTEM IN 316L STAINLESS STE
| Applicant | Synthes (Usa), Paoli PA, US |
| Decision | Substantially Equivalent for Some Indications, Jan 9, 1997 |
| Received | Aug 26, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963357
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.