510(k) K964623 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
TITANIUM CD HORIZON ANTERIOR SPINAL SYSTEM
| Applicant | Sofamor Danek USA,Inc., Memphis TN, US |
| Decision | Substantially Equivalent for Some Indications, Feb 6, 1997 |
| Received | Nov 18, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964623
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.