510(k) K042025 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
MODIFICATION TO CD HORIZON SPINAL SYSTEM
| Applicant | Medtronic Sofamor Danek, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Aug 25, 2004 |
| Received | Jul 28, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K042025
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | Medtronic Sofamor Danek USA Inc CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/DUAL LEAD THREAD, Size 6.5mm X 40mm, Mat'l TITANIUM ALLOY, REF X0809439, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memph Terminated |
KWQ | None listed |
| Jan 11, 2012 | Medtronic Sofamor Danek USA Inc CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/REDUCTION HEAD, Size 6.5mm X 40mm, Mat'l TITANIUM ALLOY, REF X1010484, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis Terminated |
KWQ | None listed |
| Jul 25, 2011 | Medtronic Sofamor Danek USA Inc CD HORIZON (R) LEGACY (TM) MAS, REF 75445540, pedicle screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132
Intended to help provide immobilization and stabilization of Terminated |
KWP | None listed |
| Jul 25, 2011 | Medtronic Sofamor Danek USA Inc ATLANTIS (R) Self-Tapping Variable Angle Screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132
Intended to help provide immobilization and stabilization of spinal segmen Terminated |
KWP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.