510(k) K113174 ยท NKB Thoracolumbosacral Pedicle Screw System
CD HORIZON SPINAL SYSTEM
| Applicant | Medtronic Sofamor Danek USA, Inc., Memphis TN, US |
| Decision | Unknown, Nov 21, 2011 |
| Received | Oct 27, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113174
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 9, 2018 | Medtronic Sofamor Danek USA Inc Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, or sacral spine.MULTI-AXIAL SCREW FO Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.