510(k) K112920 ยท MNI Orthosis, Spinal Pedicle Fixation
RANGE SPINAL SYSTEM (MESA AND DENALI)
| Applicant | K2m, Inc., Leesburg VA, US |
| Decision | Substantially Equivalent, Dec 21, 2011 |
| Received | Oct 3, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112920
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.