510(k) Report

Devices descending from K110543

808 later devices reach Crescent (R) Spinal System Titanium through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+1K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+1K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+1K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek2017144—
+1K133216Crescent Spinal SystemMedtronic Sofamor Danek, Inc.201392—
+1K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2012723—
+1K121683Acculif TL CageCoalign Innovations, Inc.2012682—
+2K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+2K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+2K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+2K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+2K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+2K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+2K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+2K163595IMPIX 3D Print CagesMedicrea International SA2017282
+2K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway20151—
+2K150847Foundation Interbody DevicesCorelink, LLC201529—
+2K140474Juliet OLSpineart2014120—
+2K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+2K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+2K133650Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2013344—
+2K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—
+2K123281Acculif TL-Peek CageCoalign Innovations, Inc.2013146—
+2K123752Acculif TL and PL CageCoalign Innovations, Inc.2013676—
+3K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+3K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+3K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+3K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+3K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+3K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+3K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+3K191134IB3D AlifMedicrea International SA20191—
+3K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+3K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+3K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+3K173518Spectrum Spine Expandable Cages (SSEC)Spectrum Spine, LLC20196—
+3K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+3K181899Roccia® PlifSilony Medical GmbH20180—
+3K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+3K181397DualXInnovasive, Inc.201815—
+3K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+3K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+3K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+3K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+3K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+3K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+3K163180Hubble IIOrbbo Surgical, LLC20160—
+3K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+3K153621Juliet® TiSpineart2016751
+3K153400ProLift Expandable SystemLife Spine, Inc.201672—
+3K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+3K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+3K151128CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015255—
+3K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+3K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+3K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+3K143616AccuLIF TL and PL CageStryker Corporation20154694
+3K141135Juliet LLSpineart2014146—
+3K141896Coroent SystemNu Vasive, Incorporated2014480—
+3K142277Juliet POSpineart2014119—
+3K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+3K133813Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc.2014137—
+3K123607Octane Elevate Spinal Implant SystemExactech, Inc.20141—
+3K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+3K132505Acculif TL and PL CageCoalign Innovations, Inc.20136453
+3K131443Coalign Innovations Acculif XL Ibf CageCoalign Innovations, Inc.20130—
+3K130194Acculif XL CageCoalign Innovations, Inc.20131—
+4K261049Scala® TLSpineart SA20260—
+4K261408SABER-XA SystemElevation Spine20260—
+4K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K260810Anteralign LS coverplateTyber Medical, LLC20260—
+4K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+4K253260ORIO-3D Cage SystemSpineCraft20260—
+4K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+4K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+4K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+4K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+4K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+4K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+4K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+4K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+4K240368E3D™-A Interbody SystemEvolution Spine20247—
+4K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+4K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+4K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+4K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K230329F3D Interbody SystemCorelink, LLC20230—
+4K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—
+4K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+4K223494CD Horizon Spinal SystemMedtronic202317—
+4K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+4K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+4K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+4K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+4K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—