510(k) Report

Devices descending from K161230

381 later devices reach NuVasive Lumbar Interbody Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+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—
+5K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+5K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+5K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+5K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+5K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+5K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+5K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+5K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+5K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+5K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+5K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+5K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+5K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+5K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+5K223418DeGen Impulse AM™ SystemDegen Medical20236—
+5K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+5K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+5K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+5K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+5K222561AlignAcuity Surgical Devices, LLC202214—
+5K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+5K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+5K220610SOLO-LAurora Spine, Inc.20220—
+5K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+5K212358Romero Cervical CageSpineup, Inc.20226—
+5K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+5K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+5K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+5K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+5K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+5K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+6K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+6K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+6K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+6K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K250769Dakota LP SystemPrecision Spine, Inc.20250—
+6K252322SIros-X SystemGenesys Spine20250—
+6K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+6K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+6K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+6K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+6K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+6K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+6K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+6K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+6K240699SCARLET® AC-TiSpineart SA20240—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+6K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+6K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+6K230026SqualeImplanet, S.A.20230—
+6K203003Pantheon IBFDPantheon Spinal20210—
+6K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+7K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+7K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+7K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+7K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+8K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+8K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—