ClearanceBrief
510(k) K060615 ยท NKB Thoracolumbosacral Pedicle Screw System

CD HORIZON SPINAL SYSTEM

ApplicantMedtronic Sofamor Danek, Memphis TN, US
DecisionSubstantially Equivalent, Oct 25, 2006
ReceivedMar 7, 2006
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K060615

DateFirm and productCodeLinked 510(k)
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
NQPNone listed
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
NQPNone listed
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
NQPNone listed
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
NQPNone listed
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
NQPNone listed
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
NQPNone listed
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
NQPNone listed
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
NQPNone listed
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
NQPNone listed
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
NQPNone listed
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
NQPNone listed
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
NQPNone listed
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
NQPNone listed
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
NQPNone listed
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
NQPNone listed
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
NQPNone listed
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
NQPNone listed
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
NQPNone listed
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
NQPNone listed
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
NQPNone listed
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
NQPNone listed
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
NQPNone listed
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
NQPNone listed
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
NQPNone listed
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
NQPNone listed
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
NQPNone listed
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
NQPNone listed
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
NQPNone listed
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
NQPNone listed
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
NQPNone listed
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
NQPNone listed
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
NQPNone listed
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
NQPNone listed
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
NQPNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.