510(k) Report

Devices descending from K080792

596 later devices reach K2M Cocr Rod through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141147Range Spinal SystemK2m, Inc.20141—
+1K140529Everest Spinal SystemK2m, LLC201431—
+1K132757Everest Spinal SystemK2m, Inc.201341—
+1K132361Everest Spinal SystemK2m, Inc.201334—
+1K131030Range Spinal SystemK2m, Inc.201334—
+1K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+1K120899Range Spinal System, Unit RodK2m, Inc.201235—
+1K120099Range Spinal System (Mesa and Denali)K2m, Inc.201253—
+1K120656Everest Spinal SystemK2m, Inc.201243—
+1K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+1K112037Range Spinal System (Mesa and Denali)K2m, Inc.201165—
+1K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC2010177—
+1K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+1K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc.20091301
+1K091266Theken Coral Spinal SystemTheken Spine, LLC200915—
+1K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+1K090230Expedium Spine SystemDepuy Spine, Inc.2009462—
+1K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc.2008518—
+2K253545Vulcan Spinal SystemK2m, Inc.20260—
+2K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+2K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+2K180337EUROPA Pedicle Screw SystemMiRus, LLC20196—
+2K182970EUROPA™ Pedicle Screw SystemMiRus, LLC20192—
+2K173508Everest Spinal SystemK2m20189—
+2K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+2K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+2K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+2K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+2K161028K2M Growing Spine SystemK2m, Inc.20163—
+2K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+2K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+2K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+2K151727Everest Spinal SystemK2m, Inc.201511—
+2K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+2K150417Astra Spine SystemSpinecraft, LLC201521—
+2K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+2K143350Nile Alternative FixationK2m, Inc.201510—
+2K142360Everest Spinal SystemK2m, Inc.201522—
+2K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+2K133402K2M Modular HooksK2m, Inc.20140—
+2K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+2K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+2K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+2K132603Apex Spine SystemSpinecraft, LLC201325—
+2K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+2K131784Range Spinal SystemK2m, Inc.201334—
+2K130877Expedium Spine SystemMedos International SARL20138—
+2K122877Range Spinal System, Small StatureK2m, Inc.201334—
+2K130330Range Spinal SystemK2m, Inc.201336—
+2K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+2K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+2K122901Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix2012116—
+2K121568Dali Spinal Fixation SystemAccel Spine20121—
+2K122145Lanx Spinal Fixation SystemLanx, Inc.201271
+2K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+2K120047Coral Spinal SystemTheken Spine, LLC201214—
+2K110551Expedium Spine SystemJohnson & Johnson20111—
+2K110906Apex Spine SystemSpinecraft, LLC2011103—
+2K111183Ascent Posterior Occipital Thoracic (Poct) System (Titanium & Cobalt Chrome Rods)Orthofix, Inc.201122—
+2K102701Viper Spine SystemDepuy Spine, Inc.2010184—
+2K101070Expedium Spine SystemMedos International SARL20102601
+2K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088—
+2K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+2K100044Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone2010117—
+2K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+2K0910675.5 Polaris Spinal SystemBiomet Spine200979—
+2K090648Viper 2 SystemDepuy Spine, Inc.2009337—
+3K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+3K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+3K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+3K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+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—
+3K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+3K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+3K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+3K223273ASTRA Spine SystemSpinecraft, LLC20228—
+3K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+3K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+3K211323ASTRA Spine SystemSpinecraft, LLC202112—
+3K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+3K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+3K200303Reform Pedicle Screw SystemPrecision Spine202010—
+3K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+3K192268Europa Pedicle Screw SystemMiRus, LLC20190—
+3K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+3K191757EUROPA Pedicle Screw SystemMiRus, LLC20191—
+3K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+3K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+3K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+3K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+3K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+3K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+3K180433Ennovate®Aesculap Implant Systems, LLC201811