510(k) Report

Devices descending from K082260

562 later devices reach Integra Cervical and Petra Plif Lumbar Cages through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+7K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+7K191134IB3D AlifMedicrea International SA20191—
+7K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+7K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+7K190885Elevation Spine Saber-C SystemElevation Spine201925—
+7K190680Favo S-TlifSilony Medical GmbH20190—
+7K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+7K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+7K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+7K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+7K180909REVEL SpacersGlobus Medical, Inc.201837—
+7K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+7K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+7K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+7K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+7K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+7K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+7K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+7K172941CASCADIA Interbody SystemK2m201852—
+7K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+7K172009Cascadia Interbody SystemK2m, Inc.2017433
+7K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+7K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+7K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+7K171704CAPRI Corpectomy Cage SystemK2m201710—
+7K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+8K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+8K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+8K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+8K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+8K261067BEE PLIF CageNGMedical GmbH20260—
+8K260660SABER-C SystemElevation Spine20261—
+8K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+8K250769Dakota LP SystemPrecision Spine, Inc.20250—
+8K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+8K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+8K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+8K250540SABER-C SystemElevation Spine20252—
+8K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+8K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+8K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+8K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+8K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+8K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+8K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+8K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+8K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+8K240368E3D™-A Interbody SystemEvolution Spine20247—
+8K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+8K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+8K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+8K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+8K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+8K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+8K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+8K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+8K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+8K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+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—
+8K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+8K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+8K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+8K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+8K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+8K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+8K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+8K223418DeGen Impulse AM™ SystemDegen Medical20236—
+8K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+8K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+8K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+8K223251Hexanium PLIFSpinevision, S.A.S.20220—
+8K223510Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc.20220—
+8K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+8K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+8K213417Ghost Spacer SystemLife Spine, Inc.20220—
+8K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+8K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+8K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+8K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+8K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+8K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+8K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+8K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+8K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+8K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+8K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+8K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+8K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—