510(k) Report

Devices descending from K090648

337 later devices reach Viper 2 System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+1K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+1K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+1K150417Astra Spine SystemSpinecraft, LLC201521—
+1K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+1K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+1K133103Aversion Pedicle Screw SystemK7, LLC20140—
+1K133369Tiger Spine SystemCorelink, LLC201429—
+1K132603Apex Spine SystemSpinecraft, LLC201325—
+1K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+1K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—
+1K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+1K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226—
+1K113044Synthes MirsSynthes Spine2011933
+1K110906Apex Spine SystemSpinecraft, LLC2011103—
+1K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+1K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+1K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+1K102701Viper Spine SystemDepuy Spine, Inc.2010184—
+1K100845Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500 SeriesZimmer Spine, Inc.201045
+2K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+2K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+2K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+2K223273ASTRA Spine SystemSpinecraft, LLC20228—
+2K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+2K211323ASTRA Spine SystemSpinecraft, LLC202112—
+2K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+2K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+2K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+2K192680Percusys® Plus Pedicle Screw SystemJoimax GmbH20190—
+2K193219G Surgical Marksman SystemG Surgical, LLC20191—
+2K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+2K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+2K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+2K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+2K171582NEO Pedicle Screw System™Neo Medical SA20170—
+2K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+2K162786PASS LP Spinal SystemMedicrea International SA20176—
+2K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+2K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+2K151727Everest Spinal SystemK2m, Inc.201511—
+2K143110GALAXY MIS Screw SystemBm Korea20152—
+2K140219Picasso II Mis Spinal SystemAccel Spine20141—
+2K132884Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20130—
+2K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company2013139—
+2K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC)20120—
+2K120838Synthes Matrix SystemSynthes Spine201216—
+2K121671Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20120—
+2K120928Synthes Matrix SystemSynthes Spine20120—
+2K120571Synthes Uss ConnectorSynthes Spine201274—
+2K121020Viper SystemDepuy Spine, Inc.201294—
+2K113058Tiger Spine SystemCorelink, LLC201281—
+2K120140Focus Spinal SystemL&K BIOMED Co., Ltd.201225—
+3K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+3K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+3K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+3K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+3K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+3K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+3K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+3K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+3K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+3K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+3K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+3K203452Nano FortiFix® SystemNanovis, LLC20200—
+3K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+3K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+3K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+3K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+3K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+3K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+3K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+3K182240PASS LP Spinal SystemMedicrea International SA20182—
+3K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+3K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+3K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+3K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH20186—
+3K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+3K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+3K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+3K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+3K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+3K161766PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.201618—
+3K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+3K161369EVEREST Spinal SystemK2m, Incorporated20169—
+3K153404Zavation Spinal SystemZavation, LLC20161—
+3K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+3K151977icotec Pedicle SystemIcotec AG201630—
+3K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+3K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+3K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+3K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+3K141850Flospine Pedicle Screw SystemFlospine20140—