510(k) Report

Devices descending from K071795

1,122 later devices reach Nuvasive Coroent System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+5K182349Concorde LiftMedos International SARL20190—
+5K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+5K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+5K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+5K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+5K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+5K181014Tritanium PL CageStryker Spine2018137—
+5K180724SPIRA Open Matrix LLIFCamber Spine Technologies, LLC201810—
+5K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+5K173537Concorde Lift™Medos International SARL20181—
+5K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+5K171519FLXfit™Expanding Orthopedics, Inc.2017711
+5K171660Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20174—
+5K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+5K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+5K160856SpineView X-Pac Expandable Lumbar Cage SystemSpine View, Inc.20165—
+5K160715AccuLIF TL and PL CageStryker Corporation20160—
+5K153695Biomet Spine Fusion SystemBiomet Spine, LLC201632
+5K142996StaXx (R) XD SystemSpine Wave, Inc.20150—
+5K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH2014461—
+5K132719Staxx Ibl SystemSpine Wave, Inc.20137—
+5K132505Acculif TL and PL CageCoalign Innovations, Inc.20136453
+5K131443Coalign Innovations Acculif XL Ibf CageCoalign Innovations, Inc.20130—
+6K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+6K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+6K263049SABER-C SystemElevation Spine20260—
+6K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+6K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+6K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+6K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+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—
+6K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+6K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+6K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+6K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+6K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+6K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+6K252322SIros-X SystemGenesys Spine20250—
+6K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+6K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+6K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+6K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+6K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+6K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+6K243188Cylox® STSignus Medizintechnik GmbH20250—
+6K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+6K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+6K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+6K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+6K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+6K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+6K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+6K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+6K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+6K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+6K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+6K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+6K240715Idys® C ZP 3DTiClariance20240—
+6K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+6K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+6K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+6K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+6K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+6K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+6K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+6K230026SqualeImplanet, S.A.20230—
+6K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+6K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+6K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+6K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+6K223251Hexanium PLIFSpinevision, S.A.S.20220—
+6K221578Hexanium ACIFSpinevision, S.A.S.20224—
+6K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+6K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+6K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+6K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+6K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+6K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+6K210728CONDUIT InstrumentsMedos International SARL20215—
+6K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+6K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+6K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+6K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+6K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+6K181792Duo™ Lumbar Interbody Fusion DeviceSpineology, Inc.20183—
+6K172756Varian cageMedyssey USA, Inc.20171—
+6K141217Acculif TL and PL CageStryker Corporation20146423
+7K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+7K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—