510(k) Report

Devices descending from K060719

992 later devices reach Modification to Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+9K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+9K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+9K223418DeGen Impulse AM™ SystemDegen Medical20236—
+9K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+9K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+9K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+9K213417Ghost Spacer SystemLife Spine, Inc.20220—
+9K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+9K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+9K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+9K220025ARx® Spinal SystemLife Spine, Inc.20220—
+9K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+9K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+9K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+9K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+9K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+9K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+9K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+9K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+9K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+9K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+9K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+9K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+9K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+9K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+9K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+9K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+9K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+9K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+9K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+9K1803473d CageFims Co., Ltd.20190—
+9K191575ARx Spinal SystemLife Spine, Inc.201910—
+9K190680Favo S-TlifSilony Medical GmbH20190—
+9K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+9K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+9K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+9K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+9K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+9K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+9K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+9K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+10K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+10K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+10K261067BEE PLIF CageNGMedical GmbH20260—
+10K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+10K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+10K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+10K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+10K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+10K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+10K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+10K233256Robotic Integration InstrumentsDePuy Synthes20240—
+10K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+10K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+10K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+10K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+10K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+10K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+10K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+10K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+10K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+10K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+10K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+10K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+10K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+10K211413BEE PLIF CageNGMedical GmbH20211—
+10K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+10K210728CONDUIT InstrumentsMedos International SARL20215—
+10K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+10K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+10K200070ARx Spinal SystemLife Spine, Inc.20209—
+11K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+11K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+11K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+11K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+11K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+11K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+11K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+11K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+11K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+11K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+11K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+11K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+11K210549ARx Spinal SystemLife Spine, Inc.20211—
+11K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+12K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+12K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+12K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+12K230880CoreLink Navigation InstrumentsCorelink, LLC20230—