510(k) K021148 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
MONARCH SPINE SYSTEM COMMERCIALLY PURE TITANIUM SPINAL ROD
| Applicant | Depuyacromed, Raynham MA, US |
| Decision | Substantially Equivalent, May 8, 2002 |
| Received | Apr 10, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K021148
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.