510(k) K122163 ยท MNI Orthosis, Spinal Pedicle Fixation
CERTEX SPINAL IMPLANT SYSTEM
| Applicant | X-Spine Systems, Inc., Miamisburg OH, US |
| Decision | Substantially Equivalent, Oct 31, 2012 |
| Received | Jul 20, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122163
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.