510(k) K121016 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
RANGE SPINAL SYSTEM (MESA AND DENALI)
| Applicant | K2m, Inc., Leesburg VA, US |
| Decision | Substantially Equivalent, Jun 27, 2012 |
| Received | Apr 4, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K121016
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.