510(k) Report

Devices descending from K980148

498 later devices reach Neurosign 800, 8 Channel Motor Nerve Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+8K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+8K240647Virage® Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20240—
+8K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+8K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+8K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+8K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+8K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+8K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+8K230087“POINT” Kinguide Agile Hybrid Navigation SystemPoint Robotics MedTech, Inc.20233—
+8K223558CUVIS-spineCurexo, Inc.20230—
+8K230989Rod Registration FrameNu Vasive, Incorporated20230—
+8K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+8K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+8K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+8K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+8K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+8K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+8K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+8K212692Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation202146—
+8K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+8K201569CUVIS-spineCurexo, Inc.20212—
+8K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+8K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+8K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+8K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+8K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+8K200896Solstice CCILife Spine, Inc.20200—
+8K191575ARx Spinal SystemLife Spine, Inc.201910—
+9K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+9K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+9K260810Anteralign LS coverplateTyber Medical, LLC20260—
+9K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+9K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+9K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+9K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+9K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+9K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+9K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+9K241846E3D™-C Interbody SystemEvolution Spine20246—
+9K241130“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)Point Robotics MedTech, Inc.20242—
+9K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+9K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+9K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+9K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+9K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+9K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+9K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+9K222698CUVIS-spineCurexo, Inc.20220—
+9K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+9K222110Mariner RDX SystemSeaSpine Orthopedics Corporation202282
+9K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+9K220025ARx® Spinal SystemLife Spine, Inc.20220—
+9K200070ARx Spinal SystemLife Spine, Inc.20209—
+10K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+10K262094E3D™-C Interbody SystemEvolution Spine20260—
+10K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+10K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+10K260038E3D™-C Interbody SystemEvolution Spine20261—
+10K252755POINT Kinguide Agile Robotic Arm Surgical Stereotactic SystemPoint Robotics MedTech, Inc.20260—
+10K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+10K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+10K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+10K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+10K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+10K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+10K240368E3D™-A Interbody SystemEvolution Spine20247—
+10K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+10K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+10K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+10K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+10K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+10K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+10K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+10K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+10K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+10K210549ARx Spinal SystemLife Spine, Inc.20211—
+10K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+11K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+11K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+11K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+11K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+11K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+11K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+11K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+11K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+11K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+11K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+11K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+11K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+12K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+12K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+12K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+13K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—