510(k) K003764 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
MODIFICATION TO EBI SPINELINK SYSTEM
| Applicant | Ebi, L.P., Parsippany NJ, US |
| Decision | Substantially Equivalent, Jan 2, 2001 |
| Received | Dec 6, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K003764
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.