510(k) K000991 ยท MNI Orthosis, Spinal Pedicle Fixation
MODIFICATION TO TSRH SPINAL SYSTEM
| Applicant | Medtronic Sofamor Danek, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Apr 18, 2000 |
| Received | Mar 28, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K000991
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.