510(k) Report

Devices descending from K023570

1,383 later devices reach Modification to Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+9K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+9K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+9K212612Omnia Medical TiBrid-SCOmnia Medical, LLC20220—
+9K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+9K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+9K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+9K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+9K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+9K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+9K210728CONDUIT InstrumentsMedos International SARL20215—
+9K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+9K202230NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC20200—
+9K200303Reform Pedicle Screw SystemPrecision Spine202010—
+9K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+9K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+9K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+9K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+9K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+9K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+9K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+9K190655SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201974—
+9K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+9K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+9K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+9K180433Ennovate®Aesculap Implant Systems, LLC201811
+9K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+9K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+9K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+9K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+9K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+9K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+9K171425Concorde LiftMedos International SARL201782
+9K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+9K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+9K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+9K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+10K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+10K253545Vulcan Spinal SystemK2m, Inc.20260—
+10K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+10K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+10K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+10K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+10K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+10K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+10K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+10K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+10K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+10K220025ARx® Spinal SystemLife Spine, Inc.20220—
+10K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+10K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+10K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+10K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+10K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+10K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+10K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+10K191575ARx Spinal SystemLife Spine, Inc.201910—
+10K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+10K182349Concorde LiftMedos International SARL20190—
+10K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+10K173537Concorde Lift™Medos International SARL20181—
+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—
+11K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+11K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+11K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+11K233256Robotic Integration InstrumentsDePuy Synthes20240—
+11K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+11K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+11K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+11K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+11K200070ARx Spinal SystemLife Spine, Inc.20209—
+11K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+12K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+12K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+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—