510(k) Report

Devices descending from K073126

304 later devices reach Expedium Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+6K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+6K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+6K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+6K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+6K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+6K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+6K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+6K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+6K193219G Surgical Marksman SystemG Surgical, LLC20191—
+6K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+6K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+6K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+6K190376PASS LP Spinal SystemMedicrea International SA201915
+6K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+6K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+6K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+6K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+6K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+6K171651Excelsius GPSGlobus Medical, Inc.2017691
+6K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+6K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+6K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+6K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+6K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+6K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+6K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+6K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+6K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+6K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+7K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+7K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+7K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+7K241525ExcelsiusXR™Globus Medical, Inc.20250—
+7K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+7K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+7K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+7K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+7K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+7K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+7K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+7K240160EGPS Navigated InstrumentsAstura Medical20240—
+7K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+7K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+7K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+7K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+7K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+7K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+7K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+7K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+7K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+7K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+7K223558CUVIS-spineCurexo, Inc.20230—
+7K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+7K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+7K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+7K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+7K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+7K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+7K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+7K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+7K220025ARx® Spinal SystemLife Spine, Inc.20220—
+7K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+7K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+7K201569CUVIS-spineCurexo, Inc.20212—
+7K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+7K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+7K203452Nano FortiFix® SystemNanovis, LLC20200—
+7K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K200303Reform Pedicle Screw SystemPrecision Spine202010—
+7K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+7K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+7K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+7K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+7K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+7K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+7K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+7K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+7K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+7K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+7K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+7K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+7K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+8K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+8K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+8K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+8K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+8K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+8K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—