510(k) Report

Devices descending from K042453

898 later devices reach Modification to Equation Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+7K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+7K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+7K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+7K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+7K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+7K182240PASS LP Spinal SystemMedicrea International SA20182—
+7K181397DualXInnovasive, Inc.201815—
+7K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+7K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+7K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+7K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+7K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+7K180433Ennovate®Aesculap Implant Systems, LLC201811
+7K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+7K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+7K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+7K173095VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with…Medos International SARL201719—
+7K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+7K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+7K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+7K171651Excelsius GPSGlobus Medical, Inc.2017691
+7K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+7K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+7K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+7K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+7K170543VIPER PRIME™ Screws with FenestrationsMedos International SARL201748—
+7K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+7K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+7K162764Jazz Frame SystemImplanet, S.A.20176—
+7K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG201671
+7K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+7K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc.20160—
+7K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161—
+7K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+7K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+7K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+7K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+7K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+7K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+7K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584—
+7K140734Nextgen Altius Oct SystemEbi, LLC20140—
+7K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+7K132765PFX Spinous Process Fixation SystemInnovasis, Inc.20140—
+7K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc.2014272
+7K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+7K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+7K121877Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod…Exactech, Inc.20134—
+7K122378Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)201271
+7K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102—
+7K113346Neon SystemUlrich GmbH & Co. KG20121—
+7K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+8K261408SABER-XA SystemElevation Spine20260—
+8K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+8K260810Anteralign LS coverplateTyber Medical, LLC20260—
+8K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+8K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+8K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+8K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+8K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+8K252742Navigated InstrumentsTyber Medical, LLC20251—
+8K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+8K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+8K241525ExcelsiusXR™Globus Medical, Inc.20250—
+8K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+8K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+8K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+8K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+8K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+8K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+8K243249TriALTIS™ Spine SystemMedos International SARL20250—
+8K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+8K243693NEO Pedicle Screw System™Neo Medical SA20240—
+8K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+8K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+8K240160EGPS Navigated InstrumentsAstura Medical20240—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+8K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+8K233256Robotic Integration InstrumentsDePuy Synthes20240—
+8K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+8K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+8K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+8K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+8K232432E3D™-A Interbody SystemEvolution Spine20248—
+8K233300POWEReam 1/4 DriveStryker Instruments20231—
+8K233684TriALTIS™ Spine SystemMedos International SARL20234—
+8K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+8K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+8K233366SYMPHONY OCT SystemMedos International SARL20230—
+8K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+8K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+8K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+8K221307Edge Upper Cervical SystemSpinal Simplicity, LLC20230—
+8K223558CUVIS-spineCurexo, Inc.20230—
+8K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+8K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+8K230614Cortium™Ulrich Medical USA20230—
+8K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+8K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—