510(k) Report

Devices descending from K061520

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161—
+1K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+1K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+1K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+1K121728Tiger Spine SystemCorelink, LLC201250—
+1K121172Reform Pedicle Screw SystemSpinal USA201233—
+1K120696Tiger Spine SystemCorelink, LLC201241—
+1K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+1K112037Range Spinal System (Mesa and Denali)K2m, Inc.201165—
+1K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+1K100605Mis SystemSpine Wave, Inc.201033—
+1K090648Viper 2 SystemDepuy Spine, Inc.2009337—
+1K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+1K070387Expedium Spine SystemDepuy Spine, Inc.2007248—
+1K071860Modification to: Viper Spine SystemDepuy Spine, Inc.2007423—
+1K062670Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated200712—
+1K061813Mantis Spinal SystemStryker Spine20061352
+2K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+2K231658VEOS Spinal Fixation SystemSpineway20230—
+2K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+2K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+2K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+2K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+2K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+2K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+2K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+2K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+2K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+2K151813Sniper Spine SystemSpine Wave, Inc.20159—
+2K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+2K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+2K150417Astra Spine SystemSpinecraft, LLC201521—
+2K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+2K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+2K142185Expedium Verse Spine SystemDepuy Spine, Inc.201420—
+2K140529Everest Spinal SystemK2m, LLC201431—
+2K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+2K133103Aversion Pedicle Screw SystemK7, LLC20140—
+2K133369Tiger Spine SystemCorelink, LLC201429—
+2K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+2K132603Apex Spine SystemSpinecraft, LLC201325—
+2K132361Everest Spinal SystemK2m, Inc.201334—
+2K131250Tiger Spine SystemCorelink, LLC201340—
+2K131343Reform Pedicle Screw SystemSpinal USA201331—
+2K130279Reform Pedicle Screw SystemSpinal USA201331—
+2K131030Range Spinal SystemK2m, Inc.201334—
+2K123164Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.201336
+2K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+2K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—
+2K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+2K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+2K120899Range Spinal System, Unit RodK2m, Inc.201235—
+2K120099Range Spinal System (Mesa and Denali)K2m, Inc.201253—
+2K120656Everest Spinal SystemK2m, Inc.201243—
+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—
+2K102870Exactech Proliant Polyaxial Pedicle Screw SystemExactech, Inc.20119—
+2K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+2K102249Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company2010218—
+2K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+2K102701Viper Spine SystemDepuy Spine, Inc.2010184—
+2K100845Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500 SeriesZimmer Spine, Inc.201045
+2K092631Mantis Redux Spinal SystemStryker Spine2009110—
+2K073562Modification to Viper Spine SystemDepuy Spine, Inc.2008213—
+2K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+2K073245Extended Vertiflex Spinal Screw SystemVertiflex, Inc.200810—
+2K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+2K073151Mantis Spinal SystemStryker Corp.2007111—
+3K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+3K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+3K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+3K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+3K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+3K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+3K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+3K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+3K223273ASTRA Spine SystemSpinecraft, LLC20228—
+3K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+3K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K211323ASTRA Spine SystemSpinecraft, LLC202112—
+3K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+3K203452Nano FortiFix® SystemNanovis, LLC20200—
+3K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+3K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+3K200303Reform Pedicle Screw SystemPrecision Spine202010—
+3K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+3K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+3K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+3K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+3K192680Percusys® Plus Pedicle Screw SystemJoimax GmbH20190—
+3K193219G Surgical Marksman SystemG Surgical, LLC20191—