510(k) Report

Devices descending from K001340

2,423 later devices reach Stackable Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K133650Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2013344—
+5K130913Genesys Spine Apache Lateral Lumbar Interbody Fusion SystemGenesys Spine201314—
+5K130317Genesys Spine Apache Ibfd Star Cervical SystemGenesys Spine20139—
+5K133207Staxx (R) SystemSpine Wave, Inc.20131—
+5K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+5K130853Idys (TM) CClariance20132—
+5K131669Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.2013234—
+5K132866Nautilus Spinal SystemLife Spine, Inc.201315—
+5K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+5K131540Interfuse L Intervertebral Body Fusion DeviceVertebral Technologies, Inc.20136—
+5K131071Staxx Ibl SystemSpine Wave, Inc.20138—
+5K131951Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.201312—
+5K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+5K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—
+5K131077Life Spine Plateau Spacer SystemLife Spine201310—
+5K131547Lanx Fusion SystemLanx, Inc.20131631
+5K121178Transcorp Acif SystemTranscorp, Inc.20130—
+5K131372Mobis IISignus Medizintechnik GmbH2013462—
+5K122588Vusion CS PlusOrtho Development Corp.2013206—
+5K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013195—
+5K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+5K122877Range Spinal System, Small StatureK2m, Inc.201334—
+5K123909Aesculap Cespace XPAesculap Implant System, Inc.20137—
+5K130646CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013244—
+5K123978Capstone L Spinal SystemMedtronic Sofamor Danek USA201313—
+5K130194Acculif XL CageCoalign Innovations, Inc.20131—
+5K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+5K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+5K123623Illico Mis Posterior Fixation SystemAlphatec Spine, Inc.201321
+5K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+5K123134Easyspine SystemLdr Spine USA, Inc.20131—
+5K123281Acculif TL-Peek CageCoalign Innovations, Inc.2013146—
+5K123752Acculif TL and PL CageCoalign Innovations, Inc.2013676—
+5K122592Instinct Java SystemZimmer Spine201301
+5K121693A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc.201221—
+5K122630IN:C2 Spinal Fixation SystemSpine Smith Partners L.P.2012405—
+5K122008Incite Anchored Cervical Interbody (Aci) Fusion DeviceIncite Innovation, LLC201210—
+5K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+5K120401Alamo TAlliance Partners, LLC20121—
+5K121728Tiger Spine SystemCorelink, LLC201250—
+5K122433CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.201239—
+5K122021Sterispine LC CageSafe Orthopaedics20122—
+5K122591Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.201214—
+5K121630Range Spinal SystemK2m, Inc.2012127—
+5K122444Cervical CageEisertech, LLC201222—
+5K121176STGCCardinal Spine, LLC201259—
+5K121320C7 Anterior Cervical Intervertebral Fusion CageMedyssey Co, Ltd.20122—
+5K121172Reform Pedicle Screw SystemSpinal USA201233—
+5K120838Synthes Matrix SystemSynthes Spine201216—
+5K121569Matisse Anterior Cervical Interbody Fusion Cage SystemAccel Spine20123—
+5K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+5K120564Calypso SystemHogan Lovells US LLP201216—
+5K121683Acculif TL CageCoalign Innovations, Inc.2012682—
+5K121211VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2012129—
+5K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+5K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+5K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+5K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+5K120840Lexus Cervical Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201214—
+5K120928Synthes Matrix SystemSynthes Spine20120—
+5K121116Plateau Spacer SystemLife Spine201213—
+5K121020Viper SystemDepuy Spine, Inc.201294—
+5K120063Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201237—
+5K120656Everest Spinal SystemK2m, Inc.201243—
+5K120696Tiger Spine SystemCorelink, LLC201241—
+5K120576Zavation Ibf SystemZavation, LLC201232—
+5K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+5K113478Plif CageEisertech, LLC2012269—
+5K113518Arena-C Cervical Intervertebral Body Fusion SystemSpinefrontier, Inc.2012193—
+5K113138Aleutian SystemK2m, Inc.2012549—
+5K113559LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic ImplantsLdr Spine USA, Inc.2011383—
+5K111123Varilift Cervical Interbody Fusion SystemWenzel Spine2011196—
+5K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+5K111512Bonebac T-Plif Intervertebral Body Fusion Device SystemThompson Mis, Inc.2011762—
+5K110783Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek CageL&K BIOMED Co., Ltd.201138—
+5K111484DiscoveryIntuitive Spine, LLC20111—
+5K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011121—
+5K110915Cervical CageEisertech, LLC201123—
+5K110864Biospine VBR SystemAesculap Implant Systems, LLC201149—
+5K110177Helena SystemRoyal Oak Medical Devices20110—
+5K102402Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer SystemAlphatec Spine, Inc.20111121
+5K101971Syntec OS Spinal Fixation SystemSyntec Scientific Corp.20110—
+5K100698STCCCardinal Spine, LLC2011346—
+5K102322Stingray Cervical Cage; Shark Implant (Plif); Bull Shark Implant (Plif); Tiger Implant…Omni Surgical, L.P.20116—
+5K101363VU Cpod Intervertebral Bodu Fusion DeviceMusculoskeletal Clinical Regulatory Advisers201078—
+5K102067Endoskeleton toTitan Spine, LLC2010337—
+5K100976T2 XVBR 1.5 Spinal SystemMedtronic Sofamor Danek USA, Inc.201049—
+5K100037Advanced Vertebral Solutions Express BFDAdvanced Vertebral Solutions, LLC20100—
+5K101288Staxx XD SystemSpine Wave, Inc.201051
+5K100820Wenzel Spine Varilift Interbody Fusion SystemWenzel Spine201016—
+5K100889Endoskeleton TCTitan Spine, LLC2010455—
+5K092325Modification to:CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20093—
+5K091883T2 Spinal SystemMedtronic Sofamor Danek USA, Inc.200951—
+5K091587Mercury Spinal SystemSpinal Elements, Inc.200910—
+5K082698Aleutian Ibf SystemK2m, Inc.2009662—
+5K082732Modification to: Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008710—
+5K082270Octane Vertebral Body Replacement (VBR) SystemVertiflex, Inc.200855—
+5K081564Creaspine Supstance Vertebral Body Replacement System Line ExtensionCreaspine20080—
+5K073285Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc.2008637—
+5K073177Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology20087751