510(k) Report

Devices descending from K071922

1,221 later devices reach Interplate Interbody Fusion Device, Models C, CGC, L and LGC through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+6K182349Concorde LiftMedos International SARL20190—
+6K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+6K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+6K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+6K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+6K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+6K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+6K181792Duo™ Lumbar Interbody Fusion DeviceSpineology, Inc.20183—
+6K181014Tritanium PL CageStryker Spine2018137—
+6K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+6K180724SPIRA Open Matrix LLIFCamber Spine Technologies, LLC201810—
+6K181188EVEREST Spinal SystemK2m, Inc.20186—
+6K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+6K173537Concorde Lift™Medos International SARL20181—
+6K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+6K171519FLXfit™Expanding Orthopedics, Inc.2017711
+6K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+6K171321K2M Navigation InstrumentsK2m201711
+6K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+6K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+6K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+6K160856SpineView X-Pac Expandable Lumbar Cage SystemSpine View, Inc.20165—
+6K160715AccuLIF TL and PL CageStryker Corporation20160—
+6K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+6K153695Biomet Spine Fusion SystemBiomet Spine, LLC201632
+6K142996StaXx (R) XD SystemSpine Wave, Inc.20150—
+6K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH2014461—
+6K132719Staxx Ibl SystemSpine Wave, Inc.20137—
+6K132505Acculif TL and PL CageCoalign Innovations, Inc.20136453
+6K131443Coalign Innovations Acculif XL Ibf CageCoalign Innovations, Inc.20130—
+7K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+7K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+7K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+7K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+7K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K261279DeltaNEC Interbody SystemNexus Spine20260—
+7K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+7K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+7K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+7K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+7K252322SIros-X SystemGenesys Spine20250—
+7K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+7K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+7K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+7K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+7K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+7K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+7K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+7K243188Cylox® STSignus Medizintechnik GmbH20250—
+7K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+7K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+7K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+7K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+7K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+7K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+7K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+7K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+7K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+7K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+7K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+7K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+7K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+7K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+7K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+7K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+7K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+7K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+7K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K230026SqualeImplanet, S.A.20230—
+7K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+7K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+7K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+7K223251Hexanium PLIFSpinevision, S.A.S.20220—
+7K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+7K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+7K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+7K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+7K210728CONDUIT InstrumentsMedos International SARL20215—
+7K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+7K201006K2M Navigation InstrumentsK2m, Inc.20200—
+7K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+7K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+7K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+7K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+7K172756Varian cageMedyssey USA, Inc.20171—
+7K141217Acculif TL and PL CageStryker Corporation20146423