510(k) Report

Devices descending from K152277

190 later devices reach PIVOX (tm) Oblique Lateral Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+1K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+1K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+1K161379ELSA SpacersGlobus Medical, Inc.2016155—
+2K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+2K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+2K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+2K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+2K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+2K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+2K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+2K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+2K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+2K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+2K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+2K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+2K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+2K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+2K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+2K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+2K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+2K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+2K181397DualXInnovasive, Inc.201815—
+2K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+2K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+3K261408SABER-XA SystemElevation Spine20260—
+3K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+3K260810Anteralign LS coverplateTyber Medical, LLC20260—
+3K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+3K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+3K252742Navigated InstrumentsTyber Medical, LLC20251—
+3K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+3K241525ExcelsiusXR™Globus Medical, Inc.20250—
+3K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+3K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+3K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+3K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+3K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+3K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+3K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+3K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+3K223494CD Horizon Spinal SystemMedtronic202317—
+3K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+3K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+3K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+3K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+3K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+3K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+3K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+3K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+3K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+3K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+3K211740DualXAmplify Surgical, Inc.20211—
+3K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+3K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+3K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+3K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+3K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+3K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+3K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+3K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+3K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+3K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+3K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+4K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+4K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+4K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+4K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+4K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+4K253331PressON Spinal Fixation SystemNexus Spine20250—
+4K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+4K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+4K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+4K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+4K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+4K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+4K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+4K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+4K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+4K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+4K241846E3D™-C Interbody SystemEvolution Spine20246—
+4K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+4K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+4K240368E3D™-A Interbody SystemEvolution Spine20247—
+4K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+4K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+4K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+4K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+4K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—