510(k) K061978 ยท MNI Orthosis, Spinal Pedicle Fixation
EBI, L.P.'S LINE EXTENSION TO THE ARRAY SPINAL SYSTEM
| Applicant | Ebi, L.P., Parsippany NJ, US |
| Decision | Substantially Equivalent, Aug 11, 2006 |
| Received | Jul 13, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K061978
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.