510(k) Report

Devices descending from K000236

79 later devices reach Synergy VLS Cap Nut Models 2206, 6102 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+1K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+1K163011PHA S1 Spinal SystemPhamedica, Inc.20170—
+1K170108Xultan 5.5 Pedicle Screw SystemMet One Technologies20172—
+1K160722CorticaLINK Spinal Fusion PlatformFacetlink Dba Linkspine20162—
+1K153404Zavation Spinal SystemZavation, LLC20161—
+1K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+1K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+1K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+1K122081Nuvasive Long Lateral Spinal SystemNuvasive, Inc.20130—
+1K120696Tiger Spine SystemCorelink, LLC201241—
+1K101682S 100 Pedicle Screw SystemRenovis Surgical Technologies, LLC20108—
+2K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+2K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+2K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+2K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+2K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+2K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+2K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+2K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+2K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+2K201568Calvary Spine Pedicle Screw SystemCalvary Spine, LLC20200—
+2K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+2K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+2K193465CorticaLINK Spinal Fusion PlatformSpine Smith Holdings, LLC20200—
+2K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+2K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+2K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+2K173484CorticaLINK Spinal Fusion PlatformLinkspine, Inc.20170—
+2K162764Jazz Frame SystemImplanet, S.A.20176—
+2K133369Tiger Spine SystemCorelink, LLC201429—
+2K131250Tiger Spine SystemCorelink, LLC201340—
+3K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+3K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+3K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+3K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+3K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+3K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+3K193219G Surgical Marksman SystemG Surgical, LLC20191—
+3K171881JAZZ Passer BandImplanet, S.A.20170—
+3K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+3K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+3K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+3K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+4K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+4K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+4K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+4K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+4K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+4K203452Nano FortiFix® SystemNanovis, LLC20200—
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+4K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+5K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+5K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+5K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+6K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+7K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—