Panels › Orthopedic › Product code NQP · Class 2
Posterior Metal/Polymer Spinal System, Fusion
Regulation 888.3070
0510(k)s in 12 months (22 all time)
0recalls in 12 months (50 all time)
50recalls that name a 510(k)
Top companies in NQP
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Sofamor Danek | 4 | 34 |
| Zimmer Inc. | 0 | 7 |
| Zimmer Spine, Inc. | 7 | 0 |
| Paradigm Spine | 5 | 0 |
| Synthes USA (HQ), Inc. | 0 | 5 |
| Synthes Spine | 0 | 4 |
| N Spine, Inc. | 2 | 0 |
| Biospine Co., Ltd. | 1 | 0 |
| Centerpulse Spine-Tech, Inc. | 1 | 0 |
| Globus Medical, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2012 | Zimmer, Inc. Dynesys Top-Loading System Cannulated Pedicle + Set Screw Terminated |
NQP | K073347 |
| Nov 6, 2012 | Zimmer, Inc. DTO" Implant Terminated |
NQP | K071879 |
| Nov 6, 2012 | Zimmer, Inc. Dynesys HA Pedicle + set screw Terminated |
NQP | K060638 |
| Nov 6, 2012 | Zimmer, Inc. Dynesys Revision + set screw Terminated |
NQP | K031511 K043565 |
| Nov 6, 2012 | Zimmer, Inc. Dynesys Universal spacer 6-45 Terminated |
NQP | K031511 |
| Nov 6, 2012 | Zimmer, Inc. Dynesys Set screw M6 Terminated |
NQP | K031511 |
| Sep 1, 2010 | Synthes USA (HQ), Inc. NFlex Stabilization System 150mm
The Synthes N-Hance and NFix II rods are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and Terminated |
NQP | K061774 K072685 |
| Sep 1, 2010 | Synthes USA (HQ), Inc. NFlex Straight monosegmental L 150mm
The Synthes N-Hance and NFix II rods are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute Terminated |
NQP | K061774 K072685 |
| Sep 1, 2010 | Synthes USA (HQ), Inc. NFix II System 150mm
The Synthes N-Hance and NFix II rods are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic inst Terminated |
NQP | K061774 K072685 |
| Sep 1, 2010 | Synthes USA (HQ), Inc. N-Hance System 150mm
The Synthes N-Hance and NFix II rods are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic inst Terminated |
NQP | K061774 K072685 |
| Sep 1, 2010 | Synthes USA (HQ), Inc. TI N-Hance Rod 150mm Sterile
The Synthes N-Hance and NFix II rods are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chro Terminated |
NQP | K061774 K072685 |
| Nov 19, 2009 | Zimmer Inc. Zimmer Dynesys top-loading cutter, spacer, Zimmer Spine, Minneapolis, MN; REF 07.01284.001. Terminated |
NQP | K073347 |
| Feb 3, 2009 | Synthes Spine TI N-Hance Rod 150 mm Sterile, Catalog number 04.600.715.02S
spinal fusion surgery Terminated |
NQP | K072685 |
| Feb 3, 2009 | Synthes Spine N-Hance System 150 mm, Catalog number NH60150-1.
spinal fusion surgery Terminated |
NQP | K072685 |
| Feb 3, 2009 | Synthes Spine NFix II System 200 mm, Catalog number NX60200-1.
spinal fusion surgery Terminated |
NQP | K061774 |
| Feb 3, 2009 | Synthes Spine NFix II System 150 mm, Catalog number NX60150-1
spinal fusion surgery Terminated |
NQP | K061774 |
| 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 | K060615 |
| 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 | K060615 |
| 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 | K060615 |
| 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 | K060615 |
| 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 | K060615 |
| 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 | K060615 |
| 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 | K060615 |
| 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 | K060615 |
| 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 | K060615 |
| 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 | K060615 |
| 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 | K060615 |
| 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 | K060615 |
| 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 | K060615 |
| 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 | K060615 |
| 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 | K060615 |
| 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 | K060615 |
| 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 | K060615 |
| 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 | K060615 |
| 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 | K060615 |
| 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 | K060615 |
| 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 | K060615 |
| 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 | K060615 |
| 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 | K060615 |
| 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 | K060615 |
| 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 | K060615 |
| 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 | K060615 |
| 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 | K060615 |
| 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 | K060615 |
| 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 | K060615 |
| 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 | K060615 |
| 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 | K060615 |
| 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 | K060615 |
| 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 | K060615 |
| 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 | K060615 |
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