510(k) K031833 ยท MNI Orthosis, Spinal Pedicle Fixation
MODIFICATION TO CD HORIZON SPINAL SYSTEM
| Applicant | Medtronic Sofamor Danek, Memphis TN, US |
| Decision | Substantially Equivalent, Sep 3, 2003 |
| Received | Jun 13, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031833
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.