510(k) K060615 ยท NKB Thoracolumbosacral Pedicle Screw System
CD HORIZON SPINAL SYSTEM
| Applicant | Medtronic Sofamor Danek, Memphis TN, US |
| Decision | Substantially Equivalent, Oct 25, 2006 |
| Received | Mar 7, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060615
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2008 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901000, 10mm, 5.5mm dia x 100mm, size: 10mm x 100mm, for spinal fixation. Terminated |
NQP | None listed |
| Sep 11, 2008 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901010, 10mm, 5.5mm dia x 110mm, size: 10mm x 110mm, for spinal fixation. Terminated |
NQP | None listed |
| Sep 11, 2008 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901020, 10mm, 5.5mm dia x 120mm, size: 10mm x 120mm, for spinal fixation. Terminated |
NQP | None listed |
| Sep 11, 2008 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901040, 10mm, 5.5mm dia x 40mm, size: 10mm x 40mm, for spinal fixation. Terminated |
NQP | None listed |
| Sep 11, 2008 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901045, 10mm, 5.5mm dia x 45mm, size: 10mm x 45mm, for spinal fixation. Terminated |
NQP | None listed |
| Sep 11, 2008 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901060, 10mm, 5.5mm dia x 60mm, size: 10mm x 60mm, for spinal fixation. Terminated |
NQP | None listed |
| Sep 11, 2008 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901070, 10mm, 5.5mm dia x 70mm, size: 10mm x 70mm, for spinal fixation. Terminated |
NQP | None listed |
| Sep 11, 2008 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901080, 10mm, 5.5mm dia x 80mm, size: 10mm x 80mm, for spinal fixation. Terminated |
NQP | None listed |
| Sep 11, 2008 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901090, 10mm, 5.5mm dia x 90mm, size: 10mm x 90mm, for spinal fixation. Terminated |
NQP | None listed |
| Sep 11, 2008 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901500, 15mm, 5.5mm dia x 100mm, size: 15mm x 100mm, for spinal fixation. Terminated |
NQP | None listed |
| Sep 11, 2008 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901510, 15mm, 5.5mm dia x 110mm, size: 15mm x 110mm, for spinal fixation. Terminated |
NQP | None listed |
| Sep 11, 2008 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901520, 15mm, 5.5mm dia x 120mm, size: 15mm x 120mm, for spinal fixation. Terminated |
NQP | None listed |
| Sep 11, 2008 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901545, 15mm, 5.5mm dia x 45mm, size: 15mm x 45mm, for spinal fixation. Terminated |
NQP | None listed |
| Sep 11, 2008 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901560, 15mm, 5.5mm dia x 60mm, size: 15mm x 60mm, for spinal fixation. Terminated |
NQP | None listed |
| Sep 11, 2008 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901570, 15mm, 5.5mm dia x 70mm, size: 15mm x 70mm, for spinal fixation. Terminated |
NQP | None listed |
| Sep 11, 2008 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901580, 15mm, 5.5mm dia x 80mm, size: 15mm x 80mm, for spinal fixation. Terminated |
NQP | None listed |
| Sep 11, 2008 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901590, 15mm, 5.5mm dia x 90mm, size: 15mm x 90mm, for spinal fixation. Terminated |
NQP | None listed |
| Sep 11, 2008 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7881000, 10mm, 5.5mm dia x 100mm, size: 10mm x 100mm, for spinal fixation, not for distribution in the U.S Terminated |
NQP | None listed |
| Sep 11, 2008 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7881010, 10mm, 5.5mm dia x 110mm, size: 10mm x 110mm, for spinal fixation, not for distribution in the U. Terminated |
NQP | None listed |
| Sep 11, 2008 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7881020, 10mm, 5.5mm dia x 120mm, size: 10mm x 120mm, for spinal fixation, not for distribution in the U. Terminated |
NQP | None listed |
| Sep 11, 2008 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7881040, 10mm, 5.5mm dia x 40mm, size: 10mm x 40mm, not for distribution in the U.S.A. or its territories Terminated |
NQP | None listed |
| Sep 11, 2008 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7881060, 10mm, 5.5mm dia x 60mm, size: 10mm x 60mm, not for distribution in the U.S.A. or its territories, Terminated |
NQP | None listed |
| Sep 11, 2008 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7881070, 10mm, 5.5mm dia x 70mm, size: 10mm x 70mm, not for distribution in the U.S.A. or its territories Terminated |
NQP | None listed |
| Sep 11, 2008 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7881080, 10mm, 5.5mm dia x 80mm, size: 10mm x 80mm, not for distribution in the U.S.A. or its territories, Terminated |
NQP | None listed |
| Sep 11, 2008 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7881090, 10mm, 5.5mm dia x 90mm, size: 10mm x 90mm, not for distribution in the U.S.A. or its territories Terminated |
NQP | None listed |
| Sep 11, 2008 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7881500, 15mm, 5.5mm dia x 100mm, size: 15mm x 100mm, not for distribution in the U.S.A. or its territori Terminated |
NQP | None listed |
| Sep 11, 2008 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7881510, 15mm, 5.5mm dia x 110mm, size: 15mm x 110mm, not for distribution in the U.S.A. or its territori Terminated |
NQP | None listed |
| Sep 11, 2008 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7881520, 15mm, 5.5mm dia x 120mm, size: 15mm x 120mm, not for distribution in the U.S.A. or its territori Terminated |
NQP | None listed |
| Sep 11, 2008 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7881545, 15mm, 5.5mm dia x 45mm, size: 15mm x 45mm, not for distribution in the U.S.A. or its territories Terminated |
NQP | None listed |
| Sep 11, 2008 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7881560, 15mm, 5.5mm dia x 60mm, size: 15mm x 60mm, not for distribution in the U.S.A. or its territorie Terminated |
NQP | None listed |
| Sep 11, 2008 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7881570, 15mm, 5.5mm dia x 70mm, size: 15mm x 70mm, not for distribution in the U.S.A. or its territorie Terminated |
NQP | None listed |
| Sep 11, 2008 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7881580, 15mm, 5.5mm dia x 80mm, size: 15mm x 80mm, not for distribution in the U.S.A. or its territories Terminated |
NQP | None listed |
| Sep 11, 2008 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7881590, 15mm, 5.5mm dia x 90mm, size: 15mm x 90mm, not for distribution in the U.S.A. or its territories Terminated |
NQP | None listed |
| Sep 11, 2008 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7881045, 10mm, 5.5mm dia x 45mm, size: 10mm x 45mm, not for distribution in the U.S.A. or its territories Terminated |
NQP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.