510(k) K991528 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR
| Applicant | Danek Medical, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, May 28, 1999 |
| Received | May 3, 1999 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K991528
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.