510(k) Report

Devices descending from K163269

143 later devices reach Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+5K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+5K223494CD Horizon Spinal SystemMedtronic202317—
+5K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+5K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+5K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+5K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+5K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+6K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+6K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+6K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+6K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+6K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+6K253331PressON Spinal Fixation SystemNexus Spine20250—
+6K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+6K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+6K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+6K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+6K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+6K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+6K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+6K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+6K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+6K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+6K223326Axiom PSR SystemRestor3D202301
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+7K252322SIros-X SystemGenesys Spine20250—
+7K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+7K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—