510(k) K911319 ยท KWP Appliance, Fixation, Spinal Interlaminal
TSRH OPEN HEAD BONE SCREW
| Applicant | Danek Medical, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Sep 6, 1991 |
| Received | Mar 26, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911319
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.