ClearanceBrief
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)
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Top companies in NQP

Company510(k)sRecalls
Medtronic Sofamor Danek434
Zimmer Inc.07
Zimmer Spine, Inc.70
Paradigm Spine50
Synthes USA (HQ), Inc.05
Synthes Spine04
N Spine, Inc.20
Biospine Co., Ltd.10
Centerpulse Spine-Tech, Inc.10
Globus Medical, Inc.10
DateFirm and productCodeLinked 510(k)
Nov 6, 2012Zimmer, Inc.
Dynesys Top-Loading System Cannulated Pedicle + Set Screw
Terminated
NQPK073347
Nov 6, 2012Zimmer, Inc.
DTO" Implant
Terminated
NQPK071879
Nov 6, 2012Zimmer, Inc.
Dynesys HA Pedicle + set screw
Terminated
NQPK060638
Nov 6, 2012Zimmer, Inc.
Dynesys Revision + set screw
Terminated
NQPK031511
K043565
Nov 6, 2012Zimmer, Inc.
Dynesys Universal spacer 6-45
Terminated
NQPK031511
Nov 6, 2012Zimmer, Inc.
Dynesys Set screw M6
Terminated
NQPK031511
Sep 1, 2010Synthes 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
NQPK061774
K072685
Sep 1, 2010Synthes 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
NQPK061774
K072685
Sep 1, 2010Synthes 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
NQPK061774
K072685
Sep 1, 2010Synthes 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
NQPK061774
K072685
Sep 1, 2010Synthes 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
NQPK061774
K072685
Nov 19, 2009Zimmer Inc.
Zimmer Dynesys top-loading cutter, spacer, Zimmer Spine, Minneapolis, MN; REF 07.01284.001.
Terminated
NQPK073347
Feb 3, 2009Synthes Spine
TI N-Hance Rod 150 mm Sterile, Catalog number 04.600.715.02S spinal fusion surgery
Terminated
NQPK072685
Feb 3, 2009Synthes Spine
N-Hance System 150 mm, Catalog number NH60150-1. spinal fusion surgery
Terminated
NQPK072685
Feb 3, 2009Synthes Spine
NFix II System 200 mm, Catalog number NX60200-1. spinal fusion surgery
Terminated
NQPK061774
Feb 3, 2009Synthes Spine
NFix II System 150 mm, Catalog number NX60150-1 spinal fusion surgery
Terminated
NQPK061774
Sep 11, 2008Medtronic 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
NQPK060615
Sep 11, 2008Medtronic 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
NQPK060615
Sep 11, 2008Medtronic 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
NQPK060615
Sep 11, 2008Medtronic 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
NQPK060615
Sep 11, 2008Medtronic 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
NQPK060615
Sep 11, 2008Medtronic 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
NQPK060615
Sep 11, 2008Medtronic 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
NQPK060615
Sep 11, 2008Medtronic 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
NQPK060615
Sep 11, 2008Medtronic 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
NQPK060615
Sep 11, 2008Medtronic 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
NQPK060615
Sep 11, 2008Medtronic 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
NQPK060615
Sep 11, 2008Medtronic 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
NQPK060615
Sep 11, 2008Medtronic 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
NQPK060615
Sep 11, 2008Medtronic 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
NQPK060615
Sep 11, 2008Medtronic 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
NQPK060615
Sep 11, 2008Medtronic 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
NQPK060615
Sep 11, 2008Medtronic 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
NQPK060615
Sep 11, 2008Medtronic 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
NQPK060615
Sep 11, 2008Medtronic 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
NQPK060615
Sep 11, 2008Medtronic 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
NQPK060615
Sep 11, 2008Medtronic 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
NQPK060615
Sep 11, 2008Medtronic 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
NQPK060615
Sep 11, 2008Medtronic 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
NQPK060615
Sep 11, 2008Medtronic 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
NQPK060615
Sep 11, 2008Medtronic 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
NQPK060615
Sep 11, 2008Medtronic 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
NQPK060615
Sep 11, 2008Medtronic 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
NQPK060615
Sep 11, 2008Medtronic 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
NQPK060615
Sep 11, 2008Medtronic 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
NQPK060615
Sep 11, 2008Medtronic 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
NQPK060615
Sep 11, 2008Medtronic 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
NQPK060615
Sep 11, 2008Medtronic 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
NQPK060615
Sep 11, 2008Medtronic 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
NQPK060615
Sep 11, 2008Medtronic 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
NQPK060615

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