510(k) K031655 ยท MNI Orthosis, Spinal Pedicle Fixation
CD HORIZON SPINAL SYSTEM
| Applicant | Medtronic Sofamor Danek USA, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Jun 27, 2003 |
| Received | May 28, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031655
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 25, 2011 | Medtronic Sofamor Danek USA Inc CD HORIZON (R) LEGACY (TM) FAS, REF 7542535, pedicle screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132
Intended to help provide immobilization and stabilization of s Terminated |
KWP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.