510(k) K110991 ยท MNI Orthosis, Spinal Pedicle Fixation
MESA SPINAL SYSTEM (KEYSTONE RODS)
| Applicant | K2m, Inc., Leesburg VA, US |
| Decision | Substantially Equivalent, Aug 2, 2011 |
| Received | Apr 8, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K110991
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.