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
+8K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+8K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+8K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+8K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+8K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+8K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+8K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+8K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+8K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+8K233359DOMINION Expandable Corpectomy SystemAstura Medical20242—
+8K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+8K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+8K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+8K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+8K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K230989Rod Registration FrameNu Vasive, Incorporated20230—
+8K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—
+8K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+8K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+8K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+8K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K203003Pantheon IBFDPantheon Spinal20210—
+8K211306LabyrinthZavation Medical Products, LLC20213—
+8K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+8K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+8K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+8K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+8K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+8K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+8K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+8K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+8K200896Solstice CCILife Spine, Inc.20200—
+8K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+8K193129Yukon OCT Spinal SystemK2m, Inc.202001
+8K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+8K182139AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc.201972—
+8K182608Oyster ACIF CageSilony Medical GmbH20190—
+8K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+8K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+8K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+8K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+8K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+8K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+8K181014Tritanium PL CageStryker Spine2018137—
+8K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+8K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+8K172941CASCADIA Interbody SystemK2m201852—
+8K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+8K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+8K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+8K171519FLXfit™Expanding Orthopedics, Inc.2017711
+8K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+8K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+8K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+8K170569SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201782—
+8K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+8K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+8K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+8K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+8K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+8K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+8K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+8K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201683—
+8K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+8K161149PASS OCT Spinal SystemMedicrea International SA20160—
+8K160756PASS OCT Spinal SystemMedicrea International SA20160—
+8K153169PASS OCT Patient Specific RodsMedicrea International20164—
+8K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+8K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+8K152211PCT SystemCentinel Spine, Inc.20150—
+8K151974Polaris Spinal SystemBiomet Spine201516—
+8K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+8K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+8K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+8K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+8K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+8K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+8K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+8K141217Acculif TL and PL CageStryker Corporation20146423
+8K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+8K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+8K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+9K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+9K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+9K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+9K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+9K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—