510(k) Report

Devices descending from K083311

554 later devices reach Aesculap Cespace Peek Intervertebral Body Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K252322SIros-X SystemGenesys Spine20250—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+8K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+8K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+8K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+8K243188Cylox® STSignus Medizintechnik GmbH20250—
+8K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+8K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+8K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+8K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+8K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+8K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+8K222561AlignAcuity Surgical Devices, LLC202214—
+8K220610SOLO-LAurora Spine, Inc.20220—
+8K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+8K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+8K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+8K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+8K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+8K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+8K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+8K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+8K182349Concorde LiftMedos International SARL20190—
+8K173537Concorde Lift™Medos International SARL20181—
+9K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+9K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+9K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+9K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+9K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+9K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+9K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+9K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+9K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+9K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+10K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+10K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+11K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—