510(k) Report

Devices descending from K041203

657 later devices reach Summit Oct Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+5K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+5K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+5K192911Brainlab Compatible K2M Navigation InstrumentsK2m, Inc.20199—
+5K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+5K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+5K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+5K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+5K183381Navigation Enabled InstrumentsStryker20191—
+5K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+5K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+5K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+5K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+5K182598VersaLink™ Fixation SystemPremia Spine, Ltd.20180—
+5K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+5K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+5K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+5K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+5K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+5K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+5K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+5K180433Ennovate®Aesculap Implant Systems, LLC201811
+5K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH20186—
+5K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+5K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+5K171582NEO Pedicle Screw System™Neo Medical SA20170—
+5K171321K2M Navigation InstrumentsK2m201711
+5K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+5K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+5K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+5K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K170647Connector SystemOrthofix, Inc.201718—
+5K170061ProMIS™ Fixation SystemPremia Spine, Ltd.20170—
+5K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+5K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+5K151727Everest Spinal SystemK2m, Inc.201511—
+5K151216Everest Spinal SystemK2m, Inc.201511—
+5K151755OASYS (r) SystemStryker Corporation201533—
+5K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+5K150417Astra Spine SystemSpinecraft, LLC201521—
+5K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+5K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+5K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+5K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+5K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+5K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+5K133402K2M Modular HooksK2m, Inc.20140—
+5K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+5K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+5K131343Reform Pedicle Screw SystemSpinal USA201331—
+5K130279Reform Pedicle Screw SystemSpinal USA201331—
+5K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+5K123373Nautilus Spinal SystemLife Spine201317—
+5K111953Nautilus Spinal SystemLife Spine20123—
+5K090320Conquest Spinal SystemLife Spine20092—
+6K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+6K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+6K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.20260—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+6K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+6K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+6K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+6K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+6K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+6K252322SIros-X SystemGenesys Spine20250—
+6K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+6K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+6K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+6K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+6K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+6K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+6K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+6K232167VySpan™ PCT SystemVy Spine, LLC20230—
+6K231479TriALTIS Spine SystemMedos International SARL20238—
+6K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+6K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+6K223806VERTICALE® Triangular Fixation SystemSilony Medical GmbH20230—
+6K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+6K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+6K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—