510(k) Report

Devices descending from K964159

281 later devices reach CD Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+1K031354Ebi OMEGA21 Spinal Fixation SystemEbi, L.P.200313—
+1K031355Ebi Spinelink - II Spinal Fixation SystemEbi, L.P.20034—
+1K980484Aesculap Spine System EvolutionAesculap, Inc.1998251—
+2K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+2K151974Polaris Spinal SystemBiomet Spine201516—
+2K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+2K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+2K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+2K082353Mercury Spinal SystemSpinal Elements, Inc.200911—
+2K083230Mercury Spinal SystemSpinal Elements, Inc.200811—
+2K042772Ebi Array Spinal Fixation System and Spinelink II Spinal Fixation DeviceEbi, L.P.20043—
+2K001080Spine System EvolutionAesculap, Inc.200062—
+2K990118Isobar Spinal SystemScien'Tx USA, Inc.1999250—
+3K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+3K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+3K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+3K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+3K200303Reform Pedicle Screw SystemPrecision Spine202010—
+3K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+3K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+3K180433Ennovate®Aesculap Implant Systems, LLC201811
+3K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+3K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+3K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+3K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+3K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+3K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+3K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+3K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+3K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+3K113755Savannah Technologies Spinal SystemSavannah Technologies, LLC20120—
+3K103573ARTS2 Spinal Fixation SystemAdvanced Medical Technologies20110—
+3K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+3K110321Tiger Spine SystemCorelink, LLC201183—
+3K091587Mercury Spinal SystemSpinal Elements, Inc.200910—
+3K070530Modification to Passmed Spinal SystemMedicrea Technologies20072—
+3K062912Scient'x Spinal SystemScient'X200736—
+3K061774Nfix II Pedicle Screw SystemN Spine, Inc.200627
+3K061162Bar Pedicle Screw Spinal Fixation System, Model 2020Applied Spine Technologies, Inc.2006131—
+3K051063Polyaxial Hemispherical Spinal ScrewsScient'X200537—
+3K040747Aladyn Rigid Spine PlateScient'X20040—
+3K033150Art Posterior Spinal SystemAdvanced Medical Technologies AG20041—
+3K020245Modification to Isobar Spinal SystemScien'Tx USA, Inc.200243—
+3K013444Isobar Spinal SystemScien'Tx USA, Inc.200194—
+3K991326Isobar Semi-Rigid Spinal SystemScien'Tx USA, Inc.19992—
+4K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+4K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+4K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+4K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+4K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+4K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K190376PASS LP Spinal SystemMedicrea International SA201915
+4K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+4K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+4K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+4K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+4K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+4K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+4K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+4K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+4K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+4K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+4K133369Tiger Spine SystemCorelink, LLC201429—
+4K131250Tiger Spine SystemCorelink, LLC201340—
+4K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+4K120838Synthes Matrix SystemSynthes Spine201216—
+4K120696Tiger Spine SystemCorelink, LLC201241—
+4K113058Tiger Spine SystemCorelink, LLC201281—
+4K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc.20091301
+4K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+4K072685Ngarde SystemN Spine, Inc.200709
+4K043001MX Polyaxial Pedicle ScrewScient'X200437—
+4K042964MX Monoaxial Pedicle ScrewScient'X200438—
+4K042953Modification to Protex Stabilization SystemGlobus Medical, Inc.20040—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+5K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+5K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+5K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+5K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K233256Robotic Integration InstrumentsDePuy Synthes20240—