510(k) K964416 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM
| Applicant | Synthes (Usa), Paoli PA, US |
| Decision | Substantially Equivalent for Some Indications, Mar 17, 1997 |
| Received | Oct 4, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964416
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.