510(k) K001037 ยท MNI Orthosis, Spinal Pedicle Fixation
MODIFICATION TO EBI SPINELINK SYSTEM
| Applicant | Ebi, L.P., Parsippany NJ, US |
| Decision | Substantially Equivalent, Apr 14, 2000 |
| Received | Mar 31, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K001037
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.