510(k) K091974 ยท NKB Thoracolumbosacral Pedicle Screw System
MODIFICATION TO CD HORIZON SPINAL SYSTEM
| Applicant | Medtronic Sofamor Danek USA, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Sep 2, 2009 |
| Received | Jul 1, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091974
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 25, 2011 | Medtronic Sofamor Danek USA Inc CD HORIZON (R) SOLERA (TM) FAS, REF 54410006035, pedicle screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132
Intended to help provide immobilization and stabilization Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.