510(k) Report

Devices descending from K031780

1,326 later devices reach Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+8K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc.201217—
+8K120998Solstice Cross ConnectorLife Spine20121—
+9K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+9K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+9K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+9K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+9K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+9K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+9K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+9K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+9K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+9K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+9K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+9K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+9K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+9K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+9K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+9K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+9K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+9K230989Rod Registration FrameNu Vasive, Incorporated20230—
+9K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+9K212612Omnia Medical TiBrid-SCOmnia Medical, LLC20220—
+9K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+9K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+9K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+9K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+9K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+9K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+9K200896Solstice CCILife Spine, Inc.20200—
+9K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+9K193129Yukon OCT Spinal SystemK2m, Inc.202001
+9K193521Steerable Plateau TiLife Spine, Inc.20201—
+9K193258ProLift Expandable SystemLife Spine, Inc.20203—
+9K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+9K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+9K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+9K190655SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201974—
+9K182349Concorde LiftMedos International SARL20190—
+9K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+9K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+9K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+9K173537Concorde Lift™Medos International SARL20181—
+9K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+9K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+9K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+9K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+9K161149PASS OCT Spinal SystemMedicrea International SA20160—
+9K160756PASS OCT Spinal SystemMedicrea International SA20160—
+9K153169PASS OCT Patient Specific RodsMedicrea International20164—
+9K152211PCT SystemCentinel Spine, Inc.20150—
+9K151974Polaris Spinal SystemBiomet Spine201516—
+9K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+9K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+9K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+9K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+9K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+9K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+9K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+10K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+10K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+10K253545Vulcan Spinal SystemK2m, Inc.20260—
+10K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+10K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+10K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+10K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+10K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+10K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+10K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+10K200303Reform Pedicle Screw SystemPrecision Spine202010—
+10K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+10K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+10K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+10K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+10K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+10K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+10K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+10K180433Ennovate®Aesculap Implant Systems, LLC201811
+10K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+10K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+10K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+10K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+10K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+10K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+11K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+11K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+11K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+11K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+11K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+11K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+11K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—