510(k) Report

Devices descending from K042268

1,620 later devices reach Ebi Cas Spine Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+6K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+6K242464Stealth™ Spine Clamps; ModuLeX™ Shank MountsMedtronic Navigation, Inc.20251—
+6K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+6K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+6K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+6K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+6K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+6K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+6K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+6K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+6K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+6K243188Cylox® STSignus Medizintechnik GmbH20250—
+6K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+6K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+6K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+6K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+6K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+6K242195Gemini Cervical Fusion Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+6K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+6K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+6K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+6K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+6K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+6K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+6K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+6K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+6K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+6K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+6K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+6K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+6K234150Lucent® XPSpinal Elements20240—
+6K233075“BioGend” Interbody Fusion System 001 CageBiogend Therapeutics Co., Ltd.20240—
+6K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+6K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+6K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+6K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+6K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+6K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+6K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+6K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+6K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+6K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+6K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+6K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+6K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+6K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+6K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+6K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+6K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+6K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+6K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+6K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+6K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+6K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+6K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+6K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+6K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+6K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+6K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+6K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+6K223326Axiom PSR SystemRestor3D202301
+6K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+6K230583Tryptik TiSpineart SA20231—
+6K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+6K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+6K223494CD Horizon Spinal SystemMedtronic202317—
+6K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+6K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+6K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+6K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+6K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+6K223251Hexanium PLIFSpinevision, S.A.S.20220—
+6K223510Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc.20220—
+6K212612Omnia Medical TiBrid-SCOmnia Medical, LLC20220—
+6K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+6K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+6K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+6K222561AlignAcuity Surgical Devices, LLC202214—
+6K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+6K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+6K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+6K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+6K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+6K220610SOLO-LAurora Spine, Inc.20220—
+6K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+6K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+6K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+6K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—