510(k) Report

Devices descending from K091813

719 later devices reach Intrepid Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+8K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+8K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+8K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+8K183064TxTi IBF SystemInnovasis, Inc.2019481
+8K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+8K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+8K182349Concorde LiftMedos International SARL20190—
+8K183092Kuros TLIF CageKuros Biosciences B.V20190—
+8K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+8K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+8K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+8K173537Concorde Lift™Medos International SARL20181—
+9K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+9K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+9K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+9K261067BEE PLIF CageNGMedical GmbH20260—
+9K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+9K253545Vulcan Spinal SystemK2m, Inc.20260—
+9K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+9K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+9K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+9K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+9K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+9K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K243474MagnetOs MISKuros Biosciences B.V20250—
+9K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+9K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+9K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+9K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+9K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+9K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+9K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+9K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+9K240453ReBOSSISOrthorebirth Co., Ltd.202402
+9K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+9K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+9K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+9K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+9K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+9K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+9K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+9K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+9K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+9K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+9K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+9K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+9K230329F3D Interbody SystemCorelink, LLC20230—
+9K221578Hexanium ACIFSpinevision, S.A.S.20224—
+9K213417Ghost Spacer SystemLife Spine, Inc.20220—
+9K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+9K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+9K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+9K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+9K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+9K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+9K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+9K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+9K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+9K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+9K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+9K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+9K211413BEE PLIF CageNGMedical GmbH20211—
+9K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+9K210728CONDUIT InstrumentsMedos International SARL20215—
+9K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+9K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+9K201287Impulse Interbody Fusion SystemDegen Medical20208—
+9K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+9K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+9K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+9K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+9K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+9K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+9K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+9K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+9K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+10K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+10K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+10K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+10K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+10K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+10K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+10K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+10K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+10K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+10K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+10K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+10K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+10K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+10K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+10K223418DeGen Impulse AM™ SystemDegen Medical20236—
+10K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+10K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+10K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+10K212358Romero Cervical CageSpineup, Inc.20226—