510(k) Report

Devices descending from K083389

633 later devices reach Coalition Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+6K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+6K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+6K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+6K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+6K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+6K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+6K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+6K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+6K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+6K203003Pantheon IBFDPantheon Spinal20210—
+6K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+6K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+6K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+6K202637F3D Corpectomy SystemCorelink, LLC20201—
+6K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+6K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+6K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+6K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+6K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+6K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+6K200312Tryptik TiSpineart20202—
+6K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+6K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+6K191134IB3D AlifMedicrea International SA20191—
+6K1803473d CageFims Co., Ltd.20190—
+6K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+6K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+6K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+6K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+6K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+6K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+6K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+6K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+6K171425Concorde LiftMedos International SARL201782
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+7K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+7K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+7K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+7K253545Vulcan Spinal SystemK2m, Inc.20260—
+7K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+7K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+7K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+7K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+7K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+7K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+7K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+7K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+7K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+7K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+7K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+7K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+7K223326Axiom PSR SystemRestor3D202301
+7K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+7K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+7K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+7K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+7K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+7K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+7K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+7K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+7K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+7K200316UNiD IB3D ALIFMedicrea International SA20200—
+7K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+7K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+7K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+7K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+7K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+7K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+7K182349Concorde LiftMedos International SARL20190—
+7K173537Concorde Lift™Medos International SARL20181—
+8K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+8K260810Anteralign LS coverplateTyber Medical, LLC20260—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+8K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+8K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K223494CD Horizon Spinal SystemMedtronic202317—
+8K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+8K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+8K213417Ghost Spacer SystemLife Spine, Inc.20220—
+8K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+8K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+8K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+8K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+8K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+8K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+8K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+9K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+9K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—