510(k) K081381 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
RANGE SPINAL SYSTEM, LARGE DENALI SCREWS
| Applicant | K2m, Inc., Leesburg VA, US |
| Decision | Substantially Equivalent, Jun 13, 2008 |
| Received | May 16, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081381
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.