510(k) Report

Devices descending from K071983

788 later devices reach Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+8K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+8K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+8K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+8K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+8K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+8K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+8K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+8K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+8K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+8K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+8K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+8K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+8K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+8K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+8K212358Romero Cervical CageSpineup, Inc.20226—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+8K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+8K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+8K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+8K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+8K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+8K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+8K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+8K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+8K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+8K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+8K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+8K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+8K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+8K171425Concorde LiftMedos International SARL201782
+9K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+9K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+9K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+9K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+9K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+9K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+9K252322SIros-X SystemGenesys Spine20250—
+9K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+9K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+9K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+9K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+9K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+9K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+9K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+9K230026SqualeImplanet, S.A.20230—
+9K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+9K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+9K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+9K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+9K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+9K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+9K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+9K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+9K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+9K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+9K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+9K182349Concorde LiftMedos International SARL20190—
+9K173537Concorde Lift™Medos International SARL20181—
+10K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+10K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+10K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+10K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+10K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+10K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+10K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+10K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+10K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+10K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+11K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+11K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—