510(k) K011067 ยท MNI Orthosis, Spinal Pedicle Fixation
MODIFICATION TO TSRH SPINAL SYSTEM
| Applicant | Medtronic Sofamor Danek, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, May 4, 2001 |
| Received | Apr 9, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011067
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.