510(k) K131343 ยท MNI Orthosis, Spinal Pedicle Fixation
REFORM PEDICLE SCREW SYSTEM
| Applicant | Spinal USA, Colorado Springs CO, US |
| Decision | Substantially Equivalent, Jul 24, 2013 |
| Received | May 9, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131343
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.