510(k) Report

Devices descending from K043020

108 later devices reach Glaxy 3.2 Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062447Traverse Oct Spinal Fixation SystemMedtronic Sofamor Danek, Inc.2007107—
+2K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011106—
+3K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.20250—
+3K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+3K140734Nextgen Altius Oct SystemEbi, LLC20140—
+3K121877Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod…Exactech, Inc.20134—
+3K122378Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)201271
+3K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102—
+4K162575Z-LINKPC SystemZavation, LLC20173—
+4K141284Caspian Spinal SystemK2m, Inc.20140—
+4K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+4K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+4K131833Centurion Poct SystemOrthofix, Inc.20142—
+4K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+4K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc.201217—
+4K120998Solstice Cross ConnectorLife Spine20121—
+5K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+5K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+5K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+5K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+5K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+5K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+5K152211PCT SystemCentinel Spine, Inc.20150—
+5K151974Polaris Spinal SystemBiomet Spine201516—
+5K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+5K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+5K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+5K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+5K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+5K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+5K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+5K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+6K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+6K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+6K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+6K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+6K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+6K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+6K200303Reform Pedicle Screw SystemPrecision Spine202010—
+6K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+6K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+6K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+6K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+6K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+6K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+6K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+6K180433Ennovate®Aesculap Implant Systems, LLC201811
+6K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+6K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+6K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+6K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+6K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+6K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+7K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+7K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+7K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+7K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+7K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+7K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+7K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+7K220025ARx® Spinal SystemLife Spine, Inc.20220—
+7K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+7K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+7K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+7K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+7K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+7K191575ARx Spinal SystemLife Spine, Inc.201910—
+7K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+7K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+7K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+7K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+8K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+8K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+8K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+8K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+8K233256Robotic Integration InstrumentsDePuy Synthes20240—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+8K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+8K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+8K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+8K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+8K200070ARx Spinal SystemLife Spine, Inc.20209—
+9K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+9K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+9K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+9K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+9K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+9K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+9K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+9K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+9K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+9K210549ARx Spinal SystemLife Spine, Inc.20211—
+9K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—