510(k) K130958 ยท MNI Orthosis, Spinal Pedicle Fixation
TRUE SPINAL FIXATION SYSTEM
| Applicant | Innovative Surgical Designs, Bloomington IN, US |
| Decision | Substantially Equivalent, Oct 17, 2013 |
| Received | Apr 5, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130958
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.