510(k) Report

Devices descending from K040482

1,621 later devices reach Ebi Esl Spine Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+9K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+9K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+9K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+9K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+9K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+9K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+9K252322SIros-X SystemGenesys Spine20250—
+9K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+9K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+9K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+9K251741PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20250—
+9K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+9K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K243474MagnetOs MISKuros Biosciences B.V20250—
+9K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+9K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+9K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+9K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+9K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+9K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+9K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+9K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+9K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+9K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+9K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+9K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+9K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+9K240453ReBOSSISOrthorebirth Co., Ltd.202402
+9K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies20241—
+9K232800Navigation Tracking InstrumentsSI-BONE, Inc.20240—
+9K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+9K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+9K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+9K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+9K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+9K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+9K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+9K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+9K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+9K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+9K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+9K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+9K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+9K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+9K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+9K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+9K211892ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)Arftx Medical, LLC20222—
+9K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+9K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+9K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+9K221244CD Horizon™ Spinal SystemMedtronic202220—
+9K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+9K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+9K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+9K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+9K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+9K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+9K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+9K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+9K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+9K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+9K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+9K202230NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC20200—
+9K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+9K201006K2M Navigation InstrumentsK2m, Inc.20200—
+9K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+9K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+9K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+9K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+9K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+9K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+9K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+9K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+9K173518Spectrum Spine Expandable Cages (SSEC)Spectrum Spine, LLC20196—
+9K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+9K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+9K181963ostaPek Interbody Fusion CagesColigne AG20181—
+9K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201810—
+9K181792Duo™ Lumbar Interbody Fusion DeviceSpineology, Inc.20183—
+9K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+9K173128Alamo® CAlliance Partners, LLC20182—
+9K172115Navigated Instrument SystemOrthofix, Inc.20184—
+9K171425Concorde LiftMedos International SARL201782
+9K162921Navigated Instrument SystemOrthofix, Inc.20175—
+9K163180Hubble IIOrbbo Surgical, LLC20160—
+9K162262Tritanium® PL CageStryker2016132—
+9K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+9K160955Tritanium® PL CageStryker2016178—
+9K160715AccuLIF TL and PL CageStryker Corporation20160—
+9K153720ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies20164—
+9K153400ProLift Expandable SystemLife Spine, Inc.201672—
+9K143450Ackermann Intervertebral Body Fusion DeviceAckermann Instrumente GmbH20150—
+9K133813Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc.2014137—