510(k) Report

Devices descending from K001340

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K162262Tritanium® PL CageStryker2016132—
+6K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+6K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+6K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+6K160074Rampart D Lumbar Interbody Fusion DeviceSpineology, Inc.20165—
+6K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+6K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+6K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+6K160856SpineView X-Pac Expandable Lumbar Cage SystemSpine View, Inc.20165—
+6K161028K2M Growing Spine SystemK2m, Inc.20163—
+6K160955Tritanium® PL CageStryker2016178—
+6K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+6K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+6K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—
+6K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+6K153404Zavation Spinal SystemZavation, LLC20161—
+6K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+6K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+6K152200SurgTech Interbody SystemSurgtech, Inc.20160—
+6K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+6K151939COALITION SpacersGlobus Medical, Inc.2016152—
+6K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+6K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+6K152651AccuLIF TL and PL CageStryker Corporation201530—
+6K151900VariLift-L Interbody Fusion DeviceWenzel Spine, Inc.20158—
+6K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA20159—
+6K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+6K151974Polaris Spinal SystemBiomet Spine201516—
+6K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+6K143479Bluefin Interbody SystemTides Medical20152—
+6K150765LDR Spine ROI-C Cervical Cage SystemLdr Spine USA201559—
+6K151727Everest Spinal SystemK2m, Inc.201511—
+6K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+6K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+6K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+6K151216Everest Spinal SystemK2m, Inc.201511—
+6K151128CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015255—
+6K151198A-CIFT SoloFuseSpinefrontier, Inc.20158—
+6K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+6K150500Px PEEK IBF SystemInnovasis, Inc.201558—
+6K150362NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2015441—
+6K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+6K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+6K150913Incite Anchored Cervical Interbody DeviceIncite Innovation20150—
+6K142392Zavation Posterior LEIFZavation, LLC20150—
+6K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+6K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+6K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+6K143360LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20159—
+6K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+6K142531F1-Modular Pedicle Screw SystemDegen Medical20152—
+6K150390Nautilus Spinal SystemLife Spine, Inc.20150—
+6K142996StaXx (R) XD SystemSpine Wave, Inc.20150—
+6K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+6K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+6K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+6K142271Zavation Z-Link LumbarZavation, LLC20149—
+6K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+6K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+6K141537IN:C2 Spinal Fixation SystmeSpine Smith Holdings, LLC20140—
+6K141896Coroent SystemNu Vasive, Incorporated2014480—
+6K142050Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated2014449—
+6K141850Flospine Pedicle Screw SystemFlospine20140—
+6K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+6K142381Xia 3 Spinal SystemStryker Corp.201483—
+6K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+6K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH2014461—
+6K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+6K140280ForticoreNanovis, LLC20149—
+6K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+6K141044M.U.S.T. ExtensionMedacta International201416—
+6K133402K2M Modular HooksK2m, Inc.20140—
+6K140921Coroent Small Interbody SystemNu Vasive, Incorporated2014444—
+6K133053Milestone Spinal SystemWeigao Orthopaedic Device Co., Ltd.20142—
+6K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+6K140709Skyhawk Interbody Fusion SystemOrthofix, Inc.20147—
+6K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+6K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+6K140303Alamo TAlliance Partners, LLC20140—
+6K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+6K140007Abacus TM Spacer SystemSpine Wave, Inc.20144—
+6K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+6K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+6K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502
+6K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+6K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc.2014471
+6K133369Tiger Spine SystemCorelink, LLC201429—
+6K132878M.U.S.T. ExtensionMedacta International201328—
+6K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+6K132757Everest Spinal SystemK2m, Inc.201341—
+6K130274Biolign Acif Systems, Biolign Stacc Acif System, Biolign Tlif SystemElite Surgical Supplies (Pty), Ltd.20139—
+6K131178Idys Lif CagesClariance201311—
+6K132303Implanet Spine SystemImplanet, S.A.201315—
+6K132719Staxx Ibl SystemSpine Wave, Inc.20137—
+6K132361Everest Spinal SystemK2m, Inc.201334—
+6K131888T2 XVBR Spinal System, T2 Altitude Expandable Corpectomy DeviceMedtronic Sofamor Danek, Inc.20130—
+6K132505Acculif TL and PL CageCoalign Innovations, Inc.20136453
+6K131250Tiger Spine SystemCorelink, LLC201340—
+6K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+6K131784Range Spinal SystemK2m, Inc.201334—