510(k) Report

Devices descending from K141665

588 later devices reach NuVasive CoRoent System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+5K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+5K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+5K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+5K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+5K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+5K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+5K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+5K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+5K243474MagnetOs MISKuros Biosciences B.V20250—
+5K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+5K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+5K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+5K243188Cylox® STSignus Medizintechnik GmbH20250—
+5K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+5K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+5K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+5K242589Scarlet® AL-TSpineart SA20240—
+5K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+5K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+5K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+5K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+5K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+5K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+5K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+5K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+5K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+5K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+5K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+5K240699SCARLET® AC-TiSpineart SA20240—
+5K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+5K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+5K234150Lucent® XPSpinal Elements20240—
+5K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+5K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+5K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+5K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+5K240453ReBOSSISOrthorebirth Co., Ltd.202402
+5K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+5K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+5K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+5K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+5K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+5K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+5K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+5K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+5K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+5K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+5K230583Tryptik TiSpineart SA20231—
+5K223418DeGen Impulse AM™ SystemDegen Medical20236—
+5K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+5K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+5K223494CD Horizon Spinal SystemMedtronic202317—
+5K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+5K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+5K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+5K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+5K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+5K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+5K222561AlignAcuity Surgical Devices, LLC202214—
+5K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+5K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+5K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+5K220610SOLO-LAurora Spine, Inc.20220—
+5K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+5K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+5K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+5K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+5K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+5K212358Romero Cervical CageSpineup, Inc.20226—
+5K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+5K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+5K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+5K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+5K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+5K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+5K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+5K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+5K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+5K200316UNiD IB3D ALIFMedicrea International SA20200—
+5K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+5K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+5K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+5K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+5K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+5K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+5K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+5K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+5K190680Favo S-TlifSilony Medical GmbH20190—
+5K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+5K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+5K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+5K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+5K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+5K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+6K261279DeltaNEC Interbody SystemNexus Spine20260—