510(k) Report

Devices descending from K102701

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+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—
+1K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+1K132603Apex Spine SystemSpinecraft, LLC201325—
+1K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+1K121020Viper SystemDepuy Spine, Inc.201294—
+1K110906Apex Spine SystemSpinecraft, LLC2011103—
+2K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+2K223273ASTRA Spine SystemSpinecraft, LLC20228—
+2K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+2K211323ASTRA Spine SystemSpinecraft, LLC202112—
+2K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+2K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+2K162786PASS LP Spinal SystemMedicrea International SA20176—
+2K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+2K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+2K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+2K113058Tiger Spine SystemCorelink, LLC201281—
+3K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+3K252322SIros-X SystemGenesys Spine20250—
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+3K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+3K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+3K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+3K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+3K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+3K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+3K221244CD Horizon™ Spinal SystemMedtronic202220—
+3K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+3K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+3K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+3K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+3K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+3K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+3K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+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—
+3K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+3K172115Navigated Instrument SystemOrthofix, Inc.20184—
+3K162921Navigated Instrument SystemOrthofix, Inc.20175—
+3K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+3K151977icotec Pedicle SystemIcotec AG201630—
+3K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+3K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+3K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+3K131250Tiger Spine SystemCorelink, LLC201340—
+3K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+3K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+4K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+4K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+4K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+4K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+4K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+4K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+4K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+4K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+4K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+4K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+4K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+4K223494CD Horizon Spinal SystemMedtronic202317—
+4K222789VADER® Pedicle System, G21 CementIcotec AG202352
+4K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+4K203023Pisces Spinal SystemOrtho Development Corporation20210—
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+4K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+4K190376PASS LP Spinal SystemMedicrea International SA201915
+4K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+4K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+4K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+4K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+4K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+4K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+4K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+4K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+4K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+4K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+4K133369Tiger Spine SystemCorelink, LLC201429—