510(k) Report

Devices descending from K071860

423 later devices reach Modification to: Viper Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161—
+1K100605Mis SystemSpine Wave, Inc.201033—
+1K090648Viper 2 SystemDepuy Spine, Inc.2009337—
+1K073562Modification to Viper Spine SystemDepuy Spine, Inc.2008213—
+1K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+2K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+2K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+2K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+2K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+2K151813Sniper Spine SystemSpine Wave, Inc.20159—
+2K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+2K150417Astra Spine SystemSpinecraft, LLC201521—
+2K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+2K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+2K133103Aversion Pedicle Screw SystemK7, LLC20140—
+2K133369Tiger Spine SystemCorelink, LLC201429—
+2K132603Apex Spine SystemSpinecraft, LLC201325—
+2K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+2K123164Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.201336
+2K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—
+2K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+2K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+2K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226—
+2K113044Synthes MirsSynthes Spine2011933
+2K111115Captiva Spine Caplox II Spinal Fixation SystemCaptiva Spine, Inc.201116—
+2K111913Capsure (R) PS SystemSpine Wave, Inc.20111—
+2K110906Apex Spine SystemSpinecraft, LLC2011103—
+2K111571Viper SystemsJohnson & Johnson2011203—
+2K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+2K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+2K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+2K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+2K102701Viper Spine SystemDepuy Spine, Inc.2010184—
+2K100845Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500 SeriesZimmer Spine, Inc.201045
+2K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+2K080767Conquest Spinal SystemLife Spine200821—
+3K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+3K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K223273ASTRA Spine SystemSpinecraft, LLC20228—
+3K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+3K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+3K211323ASTRA Spine SystemSpinecraft, LLC202112—
+3K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+3K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+3K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+3K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+3K192680Percusys® Plus Pedicle Screw SystemJoimax GmbH20190—
+3K193219G Surgical Marksman SystemG Surgical, LLC20191—
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+3K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+3K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+3K171582NEO Pedicle Screw System™Neo Medical SA20170—
+3K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+3K162786PASS LP Spinal SystemMedicrea International SA20176—
+3K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+3K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+3K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+3K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+3K151727Everest Spinal SystemK2m, Inc.201511—
+3K152174Sniper Spine SystemSpine Wave, Inc.20158—
+3K143110GALAXY MIS Screw SystemBm Korea20152—
+3K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+3K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+3K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+3K140219Picasso II Mis Spinal SystemAccel Spine20141—
+3K132884Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20130—
+3K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company2013139—
+3K123373Nautilus Spinal SystemLife Spine201317—
+3K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+3K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC)20120—
+3K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+3K121728Tiger Spine SystemCorelink, LLC201250—
+3K121172Reform Pedicle Screw SystemSpinal USA201233—
+3K111953Nautilus Spinal SystemLife Spine20123—
+3K120838Synthes Matrix SystemSynthes Spine201216—
+3K121671Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20120—
+3K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+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
+3K120696Tiger Spine SystemCorelink, LLC201241—
+3K113058Tiger Spine SystemCorelink, LLC201281—
+3K120140Focus Spinal SystemL&K BIOMED Co., Ltd.201225—
+3K090320Conquest Spinal SystemLife Spine20092—
+4K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+4K231658VEOS Spinal Fixation SystemSpineway20230—