510(k) K991036 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
DANEK PLATE AND SCREW SYSTEM
| Applicant | Sofamor Danek USA,Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Sep 14, 1999 |
| Received | Mar 29, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991036
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.