510(k) Report

Devices descending from K071860

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+4K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+4K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+4K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+4K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+4K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+4K210549ARx Spinal SystemLife Spine, Inc.20211—
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K203452Nano FortiFix® SystemNanovis, LLC20200—
+4K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+4K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+4K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+4K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+4K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+4K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+4K182240PASS LP Spinal SystemMedicrea International SA20182—
+4K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+4K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+4K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+4K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+4K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH20186—
+4K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+4K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+4K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+4K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+4K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+4K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+4K161766PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.201618—
+4K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+4K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K153404Zavation Spinal SystemZavation, LLC20161—
+4K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+4K151977icotec Pedicle SystemIcotec AG201630—
+4K160003Sniper (R) Spine SystemSpine Wave, Inc.20167—
+4K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+4K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+4K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+4K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+4K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+4K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+4K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+4K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+4K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+4K141850Flospine Pedicle Screw SystemFlospine20140—
+4K141147Range Spinal SystemK2m, Inc.20141—
+4K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+4K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+4K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+4K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+4K131250Tiger Spine SystemCorelink, LLC201340—
+4K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+4K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+4K131343Reform Pedicle Screw SystemSpinal USA201331—
+4K130279Reform Pedicle Screw SystemSpinal USA201331—
+4K131030Range Spinal SystemK2m, Inc.201334—
+4K130330Range Spinal SystemK2m, Inc.201336—
+4K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+4K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+5K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.20260—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K252322SIros-X SystemGenesys Spine20250—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+5K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+5K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+5K240392JAZZ Spinal SystemImplanet20241—
+5K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+5K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+5K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+5K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+5K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+5K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+5K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+5K223806VERTICALE® Triangular Fixation SystemSilony Medical GmbH20230—
+5K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+5K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+5K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K230762EDEN Spinal Fixation MIS SystemJmt Co., Ltd.20230—
+5K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—