510(k) Report

Devices descending from K110543

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+8K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+8K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+8K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+8K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+8K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+8K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+8K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+8K223251Hexanium PLIFSpinevision, S.A.S.20220—
+8K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+8K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+8K221578Hexanium ACIFSpinevision, S.A.S.20224—
+8K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+8K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+8K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+8K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+8K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+8K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+8K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+8K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+8K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+8K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+8K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+8K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+8K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+8K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+8K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+8K202637F3D Corpectomy SystemCorelink, LLC20201—
+8K201287Impulse Interbody Fusion SystemDegen Medical20208—
+8K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+8K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+8K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+8K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+8K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+8K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+8K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+8K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+8K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+8K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+8K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+8K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+8K1803473d CageFims Co., Ltd.20190—
+8K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+8K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+8K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+8K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+8K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+8K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+8K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+8K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+8K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+8K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+9K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+9K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+9K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+9K253545Vulcan Spinal SystemK2m, Inc.20260—
+9K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+9K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+9K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+9K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+9K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+9K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+9K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+9K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+9K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+9K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+9K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+9K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+9K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+9K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+9K230989Rod Registration FrameNu Vasive, Incorporated20230—
+9K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+9K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+9K212358Romero Cervical CageSpineup, Inc.20226—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+9K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+9K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+9K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+9K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+9K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+9K171425Concorde LiftMedos International SARL201782
+10K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+10K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+10K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+10K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+10K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+10K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+10K230026SqualeImplanet, S.A.20230—
+10K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+10K211306LabyrinthZavation Medical Products, LLC20213—