510(k) Report

Devices descending from K012254

2,058 later devices reach VBR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+5K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+5K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+5K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+5K230219Eminent Spine 3D Lumbar Interbody Fusion SystemsEminent Spine, LLC20234—
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K223043The Integrity Spine Core SystemIntegrity Spine20230—
+5K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+5K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+5K212701Eminent Spine 3D Cervical Interbody Fusion SystemEminent Spine20235—
+5K223494CD Horizon Spinal SystemMedtronic202317—
+5K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+5K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+5K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+5K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+5K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+5K220486Kentrospine PSS Pedicle Screw SystemRivarp Medical Private Limited20220—
+5K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+5K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+5K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+5K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+5K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+5K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+5K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+5K212831MectaLIF ExtensionMedacta International S.A.20211—
+5K211689KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20212—
+5K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+5K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+5K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+5K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+5K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+5K210637CD Horizon™ Spinal SystemMedtronic202134—
+5K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+5K201457Auxein Brand Vertaux 5.5 mm Pedicle Screw SystemAuxein Medical Private Limited/7116420212—
+5K203444BEE HA CageNGMedical GmbH20211—
+5K200551MectaLIF Transforaminal TiPEEKMedacta Inernational SA20214—
+5K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+5K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+5K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+5K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+5K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+5K201287Impulse Interbody Fusion SystemDegen Medical20208—
+5K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+5K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+5K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+5K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+5K202771CD Horizon Spinal SystemMedtronic202021—
+5K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+5K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+5K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+5K201585Monterey AL Interbody SystemStryker Corporation202044
+5K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+5K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+5K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+5K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+5K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+5K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+5K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+5K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+5K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+5K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+5K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+5K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+5K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+5K191796Neo Cage SystemNeo Medical SA20190—
+5K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+5K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+5K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+5K190544XIHPOS™ ZFUZE™ Interbody Fusion SystemDifusion Technologies20190—
+5K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+5K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+5K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+5K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+5K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+5K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+5K190398Republic Spine Restore Intervertebral Body Fusion SystemRepublic Spine, LLC20190—
+5K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+5K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+5K190885Elevation Spine Saber-C SystemElevation Spine201925—
+5K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+5K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+5K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+5K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+5K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+5K183381Navigation Enabled InstrumentsStryker20191—
+5K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+5K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+5K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+5K181048Neo Cage System TMNeo Medical SA20191—
+5K182477Cervical SpacerAdditive Implants, LLC201915—
+5K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+5K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+5K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+5K180909REVEL SpacersGlobus Medical, Inc.201837—
+5K181899Roccia® PlifSilony Medical GmbH20180—
+5K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+5K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+5K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—