510(k) Report

Devices descending from K061520

517 later devices reach Viper Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+3K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+3K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+3K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+3K182240PASS LP Spinal SystemMedicrea International SA20182—
+3K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+3K173508Everest Spinal SystemK2m20189—
+3K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+3K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+3K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+3K171582NEO Pedicle Screw System™Neo Medical SA20170—
+3K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+3K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+3K162786PASS LP Spinal SystemMedicrea International SA20176—
+3K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+3K161028K2M Growing Spine SystemK2m, Inc.20163—
+3K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+3K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+3K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+3K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+3K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+3K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+3K151727Everest Spinal SystemK2m, Inc.201511—
+3K152174Sniper Spine SystemSpine Wave, Inc.20158—
+3K143110GALAXY MIS Screw SystemBm Korea20152—
+3K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+3K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+3K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+3K143350Nile Alternative FixationK2m, Inc.201510—
+3K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+3K142360Everest Spinal SystemK2m, Inc.201522—
+3K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+3K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+3K142381Xia 3 Spinal SystemStryker Corp.201483—
+3K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+3K141147Range Spinal SystemK2m, Inc.20141—
+3K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+3K140219Picasso II Mis Spinal SystemAccel Spine20141—
+3K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+3K132884Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20130—
+3K132757Everest Spinal SystemK2m, Inc.201341—
+3K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company2013139—
+3K131784Range Spinal SystemK2m, Inc.201334—
+3K122877Range Spinal System, Small StatureK2m, Inc.201334—
+3K130330Range Spinal SystemK2m, Inc.201336—
+3K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+3K122845ES2 Spinal System Model 48280XXXXStryker Spine201228—
+3K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC)20120—
+3K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+3K122145Lanx Spinal Fixation SystemLanx, Inc.201271
+3K120838Synthes Matrix SystemSynthes Spine201216—
+3K121671Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20120—
+3K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+3K120928Synthes Matrix SystemSynthes Spine20120—
+3K120571Synthes Uss ConnectorSynthes Spine201274—
+3K121020Viper SystemDepuy Spine, Inc.201294—
+3K120292Caplox II Pedicle Screw SystemCaptiva Spine, Inc.2012151
+3K113058Tiger Spine SystemCorelink, LLC201281—
+3K120140Focus Spinal SystemL&K BIOMED Co., Ltd.201225—
+3K102235Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine2010109—
+3K080767Conquest Spinal SystemLife Spine200821—
+4K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+4K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+4K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K253249TriALTIS™ Spine SystemMedos International SARL20251—
+4K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+4K252437JAZZ Spinal SystemImplanet20250—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+4K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+4K240392JAZZ Spinal SystemImplanet20241—
+4K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+4K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+4K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+4K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+4K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+4K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+4K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+4K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+4K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—