510(k) Report

Devices descending from K140055

267 later devices reach Endoskeleton (R) TL Interbody Fusion Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+7K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+7K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+7K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+7K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+7K253260ORIO-3D Cage SystemSpineCraft20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K252322SIros-X SystemGenesys Spine20250—
+7K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+7K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+7K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+7K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+7K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+7K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+7K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K223418DeGen Impulse AM™ SystemDegen Medical20236—
+7K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+7K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+7K222561AlignAcuity Surgical Devices, LLC202214—
+7K220610SOLO-LAurora Spine, Inc.20220—
+7K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+7K202637F3D Corpectomy SystemCorelink, LLC20201—
+7K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+7K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+7K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+7K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+8K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K261279DeltaNEC Interbody SystemNexus Spine20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K250769Dakota LP SystemPrecision Spine, Inc.20250—
+8K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+8K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+8K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+8K230329F3D Interbody SystemCorelink, LLC20230—
+8K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+8K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+8K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+8K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+9K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+9K240699SCARLET® AC-TiSpineart SA20240—
+9K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+9K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+9K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+10K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+11K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—