510(k) Report

Devices descending from K161379

155 later devices reach ELSA Spacers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+1K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+1K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+1K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+1K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+1K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+1K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+1K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+1K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+1K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+1K181397DualXInnovasive, Inc.201815—
+1K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+1K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+2K261408SABER-XA SystemElevation Spine20260—
+2K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+2K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+2K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+2K241525ExcelsiusXR™Globus Medical, Inc.20250—
+2K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+2K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+2K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+2K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+2K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+2K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+2K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+2K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+2K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+2K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+2K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+2K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+2K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+2K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+2K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+2K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+2K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+2K211740DualXAmplify Surgical, Inc.20211—
+2K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+2K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+2K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+2K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+2K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+2K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+2K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+2K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+2K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+2K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+2K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+3K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+3K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+3K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+3K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+3K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+3K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+3K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+3K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+3K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+3K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+3K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+3K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+3K241846E3D™-C Interbody SystemEvolution Spine20246—
+3K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+3K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+3K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+3K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+3K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+3K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+3K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+3K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+3K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+3K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+3K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+3K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+3K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+3K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+3K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+3K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+3K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+3K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+3K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+3K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+4K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+4K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+4K262094E3D™-C Interbody SystemEvolution Spine20260—
+4K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+4K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+4K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+4K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+4K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+4K260038E3D™-C Interbody SystemEvolution Spine20261—
+4K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+4K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+4K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+4K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+4K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—