510(k) Report

Devices descending from K100788

374 later devices reach Cocr Rods through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173131Rexious Spinal Fixation SystemHuvexel Co., Ltd.20175—
+1K140238Excella Iii-D Spinal Deformity SystemInnovasis, Inc.201432
+1K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+1K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+1K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+1K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+1K111449Revolve Additional ImplantsGlobus Medical, Inc.2011236—
+1K111479Revere CrosstopGlobus Medical, Inc.2011232—
+1K103671Genesys Spine Tilock SystemGenesys Spine20118—
+1K110963Ellipse Occipito-Cervico-Thoracic Spinal SystemGlobus Medical, Inc.201198—
+1K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC2010177—
+2K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+2K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+2K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+2K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+2K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+2K222415Rexious Spinal Fixation SystemDio Medical Corporation20221—
+2K220285PINE Pedicle Screw SystemTdm Co., Ltd.20220—
+2K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+2K210420Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc.20211—
+2K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+2K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+2K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+2K173508Everest Spinal SystemK2m20189—
+2K172469TiLock Modular Spinal SystemGenesys Spine20170—
+2K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+2K171651Excelsius GPSGlobus Medical, Inc.2017691
+2K171838TiLock2 Spinal SystemGenesys Spine20174—
+2K162143FixxSure® X-LinkInnovasis, Inc.20160—
+2K161914Genesys Spine TiLock Cortical Spinal SystemGenesys Spine20161—
+2K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine20157—
+2K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+2K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+2K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+2K150417Astra Spine SystemSpinecraft, LLC201521—
+2K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+2K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+2K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+2K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+2K132603Apex Spine SystemSpinecraft, LLC201325—
+2K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+2K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+2K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+2K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+2K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+2K121568Dali Spinal Fixation SystemAccel Spine20121—
+2K112607Spinevision Lumis (TM) Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…Spinevision S.A.20125—
+2K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+2K110906Apex Spine SystemSpinecraft, LLC2011103—
+3K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+3K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…MANTIZ Co., Ltd.20260—
+3K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+3K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+3K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+3K252322SIros-X SystemGenesys Spine20250—
+3K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+3K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+3K241525ExcelsiusXR™Globus Medical, Inc.20250—
+3K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+3K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+3K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+3K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+3K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+3K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+3K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K240160EGPS Navigated InstrumentsAstura Medical20240—
+3K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+3K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+3K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+3K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+3K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+3K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+3K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+3K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+3K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+3K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+3K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+3K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+3K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+3K223558CUVIS-spineCurexo, Inc.20230—
+3K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+3K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+3K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+3K223273ASTRA Spine SystemSpinecraft, LLC20228—
+3K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+3K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+3K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+3K211323ASTRA Spine SystemSpinecraft, LLC202112—
+3K201569CUVIS-spineCurexo, Inc.20212—
+3K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+3K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+3K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+3K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+3K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—