510(k) Report

Devices descending from K113447

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+2K153400ProLift Expandable SystemLife Spine, Inc.201672—
+2K152539SpineView X-Pac Expandable Lumbar Cage SystemSpine View, Inc.20166—
+2K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+2K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+2K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+2K142498MAGNIFY and MAGNIFY-S SpacersGlobus Medical, Inc.2015175—
+2K140716Opticage Expandable Interbody Fusion DeviceInterventional Spine, Inc.20140—
+2K140411Altera SpacerGlobus Medical, Inc.201419122
+3K261408SABER-XA SystemElevation Spine20260—
+3K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+3K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+3K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+3K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+3K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+3K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+3K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+3K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+3K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+3K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+3K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+3K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+3K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+3K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+3K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+3K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+3K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+3K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+3K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+3K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+3K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+3K241846E3D™-C Interbody SystemEvolution Spine20246—
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+3K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+3K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+3K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+3K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+3K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+3K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+3K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+3K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+3K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+3K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+3K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+3K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+3K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+3K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+3K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—
+3K220902Navagio Lumbar CageKalitec Medical, LLC20220—
+3K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+3K220655X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20222—
+3K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+3K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+3K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+3K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+3K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+3K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+3K203802X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20213—
+3K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+3K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+3K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+3K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+3K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+3K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+3K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+3K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+3K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+3K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+3K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+3K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+3K201145X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20204—
+3K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+3K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+3K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+3K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+3K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+3K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+3K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+3K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+3K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+3K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+3K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+3K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+3K190885Elevation Spine Saber-C SystemElevation Spine201925—
+3K183243Velofix TLIF CageU&I Corporation20190—
+3K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+3K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+3K180909REVEL SpacersGlobus Medical, Inc.201837—
+3K182584Lucent® XPSpinal Elements, Inc.20183—
+3K182470Plateau Spacer SystemLife Spine20180—
+3K181829Velofix TLIF CageU&I Corporation20181—
+3K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+3K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+3K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+3K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+3K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—