510(k) K964159 ยท KWP Appliance, Fixation, Spinal Interlaminal
CD SPINAL SYSTEM
| Applicant | Sofamor Danek USA,Inc., Memphis TN, US |
| Decision | Substantially Equivalent for Some Indications, Oct 16, 1997 |
| Received | Oct 16, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964159
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.