510(k) Report

Devices descending from K040536

1,150 later devices reach Modification to Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+8K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+8K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+8K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+8K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+8K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+8K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+8K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+8K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+8K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+8K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+8K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+8K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+8K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+8K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+8K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+8K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+8K234150Lucent® XPSpinal Elements20240—
+8K240715Idys® C ZP 3DTiClariance20240—
+8K233359DOMINION Expandable Corpectomy SystemAstura Medical20242—
+8K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+8K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+8K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+8K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+8K233366SYMPHONY OCT SystemMedos International SARL20230—
+8K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+8K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+8K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+8K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+8K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+8K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+8K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+8K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+8K221307Edge Upper Cervical SystemSpinal Simplicity, LLC20230—
+8K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+8K230614Cortium™Ulrich Medical USA20230—
+8K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+8K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+8K230026SqualeImplanet, S.A.20230—
+8K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+8K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+8K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+8K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+8K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+8K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+8K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+8K221578Hexanium ACIFSpinevision, S.A.S.20224—
+8K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+8K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+8K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+8K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+8K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+8K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+8K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+8K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+8K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+8K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+8K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+8K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+8K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+8K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+8K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+8K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+8K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+8K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+8K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+8K210359Hexanium TLIFSpinevision, S.A.S.20211—
+8K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+8K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+8K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+8K202637F3D Corpectomy SystemCorelink, LLC20201—
+8K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+8K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+8K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+8K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+8K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+8K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+8K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+8K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+8K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+8K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+8K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+8K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+8K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+8K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+8K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+8K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+8K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+8K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+8K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+8K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+8K192897icotec Cervical CageIcotec AG20201—
+8K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+8K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+8K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+8K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+8K193521Steerable Plateau TiLife Spine, Inc.20201—
+8K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+8K192687TrellOss™-L MPFNexxt Spine, LLC20201—