510(k) Report

Devices descending from K043561

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+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—
+9K200303Reform Pedicle Screw SystemPrecision Spine202010—
+9K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+9K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+9K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+9K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+9K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+9K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+9K1803473d CageFims Co., Ltd.20190—
+9K190680Favo S-TlifSilony Medical GmbH20190—
+9K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+9K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+9K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+9K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+9K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+9K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+9K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+9K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+9K180433Ennovate®Aesculap Implant Systems, LLC201811
+9K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+9K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+9K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+9K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+9K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+9K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+9K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+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—
+10K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+10K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+10K261067BEE PLIF CageNGMedical GmbH20260—
+10K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+10K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+10K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+10K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+10K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+10K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+10K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+10K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+10K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+10K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+10K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+10K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+10K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+10K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+10K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+10K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+10K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+10K223418DeGen Impulse AM™ SystemDegen Medical20236—
+10K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+10K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+10K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+10K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+10K220025ARx® Spinal SystemLife Spine, Inc.20220—
+10K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+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—
+10K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+10K211413BEE PLIF CageNGMedical GmbH20211—
+10K210728CONDUIT InstrumentsMedos International SARL20215—
+10K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+10K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+10K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+10K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+10K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+10K191575ARx Spinal SystemLife Spine, Inc.201910—
+10K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+10K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+10K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+11K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+11K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+11K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+11K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+11K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+11K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+11K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+11K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+11K233256Robotic Integration InstrumentsDePuy Synthes20240—
+11K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+11K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+11K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+11K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+11K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+11K200070ARx Spinal SystemLife Spine, Inc.20209—
+12K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+12K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+12K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+12K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+12K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+12K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+12K210549ARx Spinal SystemLife Spine, Inc.20211—
+12K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+13K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+13K230880CoreLink Navigation InstrumentsCorelink, LLC20230—