510(k) Report

Devices descending from K070229

598 later devices reach Range Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+5K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+5K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+5K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+5K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+5K240963Spinal SystemTeslake, Inc.20240—
+5K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+5K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+5K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+5K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+5K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+5K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+5K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+5K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+5K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+5K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+5K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+5K222789VADER® Pedicle System, G21 CementIcotec AG202352
+5K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+5K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+5K220025ARx® Spinal SystemLife Spine, Inc.20220—
+5K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+5K203023Pisces Spinal SystemOrtho Development Corporation20210—
+5K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+5K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+5K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+5K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+5K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+5K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+5K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+5K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+5K192680Percusys® Plus Pedicle Screw SystemJoimax GmbH20190—
+5K193219G Surgical Marksman SystemG Surgical, LLC20191—
+5K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+5K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+5K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+5K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+5K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+5K190376PASS LP Spinal SystemMedicrea International SA201915
+5K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+5K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+5K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+5K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+5K171582NEO Pedicle Screw System™Neo Medical SA20170—
+5K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+5K172194Connector SystemOrthofix, Inc.2017162
+5K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+5K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+5K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+5K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+5K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+5K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+5K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+5K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+5K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+5K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+5K151974Polaris Spinal SystemBiomet Spine201516—
+5K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+5K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+5K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+5K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+5K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+5K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+5K143110GALAXY MIS Screw SystemBm Korea20152—
+5K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+5K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+5K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+5K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+5K140219Picasso II Mis Spinal SystemAccel Spine20141—
+5K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+5K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+5K132884Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20130—
+5K132303Implanet Spine SystemImplanet, S.A.201315—
+5K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company2013139—
+5K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+5K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+5K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+5K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+5K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+5K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+5K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+5K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC)20120—
+5K120838Synthes Matrix SystemSynthes Spine201216—
+5K121671Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20120—
+5K120928Synthes Matrix SystemSynthes Spine20120—
+5K120571Synthes Uss ConnectorSynthes Spine201274—
+5K120140Focus Spinal SystemL&K BIOMED Co., Ltd.201225—
+6K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+6K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+6K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+6K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+6K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+6K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—