510(k) Report

Devices descending from K113447

691 later devices reach Rise Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+1K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+1K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+1K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+1K232069Expandable Lumbar Fusion Cage (Type I,Type II)Shanghai Reach Medical Instrument Co, Ltd.20230—
+1K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+1K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+1K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—
+1K221687Pegasus-X Expandable PLIF SystemGS Medical Co., Ltd.20220—
+1K213441PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20222—
+1K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+1K211740DualXAmplify Surgical, Inc.20211—
+1K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+1K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+1K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+1K190488ProLift Expandable SystemLife Spine, Inc.201916—
+1K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+1K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+1K181397DualXInnovasive, Inc.201815—
+1K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+1K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+1K153786Prow Fusion-VNlt Spine, Ltd.20166—
+1K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+1K151481Sahara Stabilization SystemK2m, Inc.20155—
+1K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+1K123231Caliber SpacersGlobus Medical, Inc.2013657—
+1K122097Patriot SpacersGlobus Medical, Inc.2012261—
+2K261049Scala® TLSpineart SA20260—
+2K261430TruLift Expandable SystemLife Spine, Inc.20260—
+2K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+2K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+2K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+2K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+2K241525ExcelsiusXR™Globus Medical, Inc.20250—
+2K251741PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20250—
+2K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+2K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+2K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+2K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+2K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+2K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+2K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+2K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+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
+2K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+2K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+2K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+2K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+2K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+2K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+2K222797X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20221—
+2K213417Ghost Spacer SystemLife Spine, Inc.20220—
+2K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+2K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+2K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+2K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+2K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+2K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+2K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+2K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+2K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+2K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+2K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+2K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+2K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+2K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+2K201585Monterey AL Interbody SystemStryker Corporation202044
+2K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+2K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+2K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+2K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+2K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+2K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+2K193521Steerable Plateau TiLife Spine, Inc.20201—
+2K193258ProLift Expandable SystemLife Spine, Inc.20203—
+2K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+2K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+2K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+2K173518Spectrum Spine Expandable Cages (SSEC)Spectrum Spine, LLC20196—
+2K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+2K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+2K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+2K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+2K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+2K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+2K172419Velofix™ TLIF CageU&I Corporation20172—
+2K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+2K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+2K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+2K161379ELSA SpacersGlobus Medical, Inc.2016155—
+2K153665Prow Fusion-LNlt Spine, Ltd.20160—
+2K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+2K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+2K152011Lucent Intervertebral Body Fusion DeviceSpinal Elements, Inc.2016106—
+2K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+2K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+2K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—