510(k) K991031 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
COLORADO II SPINAL SYSTEM
| Applicant | Sofamor Danek USA,Inc., Memphis TN, US |
| Decision | Substantially Equivalent, May 10, 2000 |
| Received | Mar 29, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991031
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 7, 2008 | Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK Medtronic Sofamor Danek COLORADO 2" SPINAL SYSTEM Break-Off Nut, non-sterile, RX; Catalog Number 8634111, Medtronic, Memphis, TN 38138. Terminated |
KWP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.