510(k) Report

Devices descending from K001340

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+4K140770MLX - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2014269—
+4K132907Plif Lite and Tlif LiteSintea Plustek20140—
+4K140142Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP2014172—
+4K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+4K140162AP Expandable Xlif SystemNuvasive, Inc.2014236—
+4K140411Altera SpacerGlobus Medical, Inc.201419122
+4K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+4K133418Integra Expandable Interverebral Body Fusion Device (Ibd) SystemSeaspine, Inc.20145—
+4K133514Xcage Interbody Fusion SystemOuroboros Medical201415—
+4K132999Cervical Stand Alone SystemOrthofix, Inc.2014281—
+4K133614Aleutian Ibf SystemK2m, Inc.2014527—
+4K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+4K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+4K133455Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc.20145961
+4K140106S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014265—
+4K133893Sterispine LC CageSafe Orthopaedics20141—
+4K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+4K133623C-PLUSPioneer Surgical Technology, Inc.2014598—
+4K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+4K133967Interbody Cage SystemAurora Spine2014227—
+4K133192Mectalif TipeekMedacta International201416—
+4K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+4K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+4K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+4K132897Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.2013279—
+4K132328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013176—
+4K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+4K132639CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013243—
+4K133216Crescent Spinal SystemMedtronic Sofamor Danek, Inc.201392—
+4K132718Integrity Spine Core SystemIntegrity Spine20131—
+4K132014GSB Global Spinal Balance SystemNuvasive, Inc.201382—
+4K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+4K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+4K132700Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek, Inc.2013170—
+4K131723Coroent Single Tab SystemNuvasive, Inc.2013466—
+4K131296Varilift-L Interbody Fusion DeviceWenzel Spine, Inc.20130—
+4K130948C-Fuse Cervical Intervertebral Body Fusion SystemSouthern Spine, LLC201313—
+4K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013100—
+4K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314—
+4K124012Infill Oblique Tlif DevicePinnacle Spine Group, LLC20136—
+4K130699Aleutian Spinal SystemK2m, Inc.2013570—
+4K130445Vault Alif SystemSpinal USA20139—
+4K123461Staxx (R) IB SystemSpine Wave, Inc.2013251
+4K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+4K123767Lanx Fusion System- SALanx, Inc.20133244
+4K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+4K123809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20136—
+4K123206Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical2013454—
+4K123969XiphosDifusion Technologies201314—
+4K120464Innesis Peek CageBk Meditech, Co., Ltd.20136—
+4K123231Caliber SpacersGlobus Medical, Inc.2013657—
+4K123180Falcon SpacerSynthes (USA) Products, LLC2013147—
+4K123388K7C SpacerK7, LLC20130—
+4K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+4K123207Primalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion SystemOsteomed LP201216—
+4K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+4K121151Pro-Link Cervical Spacer SystemLife Spine, Inc.2012116—
+4K121581Box Peek VBR System,Innovasis, Inc.20121—
+4K122366Tryptik CC Anterior Intersomatic Cervical CageSpineart20125—
+4K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012211—
+4K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine20125—
+4K120819Stalif CCentinel Spine, Inc.2012206—
+4K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2012723—
+4K121103LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior Spinal…Ldr Spine USA, Inc.201216—
+4K113285LDR Spine Usa Avenue L Interbody FusionLdr Spine USA, Inc.2012199—
+4K121982Sovereign Spinal SystemMedtronic Sofamor Danek2012155—
+4K121733Infill Intervertebral Body Fusion DevicePinnacle Spine Group, LLC201221—
+4K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201236—
+4K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012357—
+4K121107Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R)Globus Medical, Inc.2012214—
+4K120345Honour Spacer SystemNexxt Spine, LLC2012212—
+4K112986Lateral Fusion DeviceIntegra Spine (Integra Lifesciences)2012126—
+4K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+4K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc.2012761—
+4K120101Independence SpacerGlobus Medical, Inc.2012224—
+4K113529CD Horizon Voyager Spinal SystemMedtronic Sofamor Danek2012316—
+4K113642Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA2012292—
+4K113447Rise SpacerGlobus Medical, Inc.2012691—
+4K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+4K113527Opticage Interbody Fusion DeviceInterventional Spine, Inc.2012103—
+4K112664Zavation Ibf SystemsZavation, LLC201137—
+4K113528Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011361—
+4K113465Acculif TL CageCoalign Innovations, Inc.2011718—
+4K112095Acculif TL-Peek Ibf CageCoalign Innovations, Inc.2011319—
+4K112493Pass LP Spinal SystemMedicrea International20111—
+4K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20115961
+4K111965Vusion (R) OSOrtho Development20110—
+4K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011597—
+4K112496Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc.2011604—
+4K112555CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011597—
+4K111510CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011128—
+4K110659Medical Concepts Interbody Fusion SystemMedical Concepts, Inc.20111—
+4K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC201123—
+4K111525Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2011355—
+4K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+4K102315Staxx XDL SystemSpine Wave, Inc.20113—
+4K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011808—
+4K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+4K100305Eturn Spinal Implant Model Eturn XX-12; Eturn XX-16 Where XX=07, 09, 11, 13, or 15 and…Icotec20118—