510(k) K111127 ยท MNI Orthosis, Spinal Pedicle Fixation
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
| Applicant | Spineart, Geneva, CH |
| Decision | Substantially Equivalent, Aug 11, 2011 |
| Received | Apr 21, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K111127
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.