510(k) K100354 ยท KWP Appliance, Fixation, Spinal Interlaminal
PRIMAL OK INTERSPINOUS FUSION SYSTEM
| Applicant | Osteomed LP, Chesterland OH, US |
| Decision | Substantially Equivalent, Aug 17, 2010 |
| Received | Feb 12, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100354
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.