510(k) Report

Devices descending from K113478

269 later devices reach Plif Cage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+5K232315Catalyst Bone Void FillerOssdsign AB20237—
+5K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+5K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+5K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+5K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+5K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+5K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+5K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+5K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+5K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+5K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+5K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+5K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+5K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+5K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+5K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+5K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+5K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+5K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+5K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+5K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+5K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+5K183092Kuros TLIF CageKuros Biosciences B.V20190—
+5K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+6K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+6K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+6K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K253260ORIO-3D Cage SystemSpineCraft20260—
+6K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+6K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+6K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+6K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+6K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K243474MagnetOs MISKuros Biosciences B.V20250—
+6K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+6K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+6K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+6K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—
+6K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+6K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+6K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+6K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+6K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+6K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+6K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+6K240453ReBOSSISOrthorebirth Co., Ltd.202402
+6K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+6K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+6K232432E3D™-A Interbody SystemEvolution Spine20248—
+6K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+6K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+6K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+6K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+6K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+6K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+6K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+6K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+6K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+6K223494CD Horizon Spinal SystemMedtronic202317—
+6K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+6K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+6K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+6K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+6K213417Ghost Spacer SystemLife Spine, Inc.20220—
+6K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+6K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+6K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+6K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+6K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+6K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+6K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+6K201287Impulse Interbody Fusion SystemDegen Medical20208—
+6K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+6K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+6K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+6K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+6K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—