510(k) Report

Devices descending from K070229

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+1K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+1K171321K2M Navigation InstrumentsK2m201711
+1K161028K2M Growing Spine SystemK2m, Inc.20163—
+1K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+1K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+1K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+1K141147Range Spinal SystemK2m, Inc.20141—
+1K140529Everest Spinal SystemK2m, LLC201431—
+1K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+1K132757Everest Spinal SystemK2m, Inc.201341—
+1K132361Everest Spinal SystemK2m, Inc.201334—
+1K131784Range Spinal SystemK2m, Inc.201334—
+1K131030Range Spinal SystemK2m, Inc.201334—
+1K130330Range Spinal SystemK2m, Inc.201336—
+1K123412Range Spinal System, Small Strature ComponentsK2m, 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—
+1K112920Range Spinal System (Mesa and Denali)K2m, Inc.201149—
+1K112037Range Spinal System (Mesa and Denali)K2m, Inc.201165—
+1K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC2010177—
+1K080792K2M Cocr RodK2m, Inc.2008596—
+2K253545Vulcan Spinal SystemK2m, Inc.20260—
+2K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+2K201006K2M Navigation InstrumentsK2m, Inc.20200—
+2K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+2K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+2K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+2K180376K2M Patient Specific RodsK2m, Inc.20182—
+2K173508Everest Spinal SystemK2m20189—
+2K161369EVEREST Spinal SystemK2m, Incorporated20169—
+2K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+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—
+2K132603Apex Spine SystemSpinecraft, LLC201325—
+2K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+2K122877Range Spinal System, Small StatureK2m, Inc.201334—
+2K121568Dali Spinal Fixation SystemAccel Spine20121—
+2K122145Lanx Spinal Fixation SystemLanx, Inc.201271
+2K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+2K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+2K110906Apex Spine SystemSpinecraft, LLC2011103—
+2K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+2K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc.20091301
+2K091266Theken Coral Spinal SystemTheken Spine, LLC200915—
+2K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+2K090230Expedium Spine SystemDepuy Spine, Inc.2009462—
+2K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc.2008518—
+3K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+3K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+3K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+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—
+3K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+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—
+3K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+3K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+3K211323ASTRA Spine SystemSpinecraft, LLC202112—
+3K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+3K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+3K180337EUROPA Pedicle Screw SystemMiRus, LLC20196—
+3K182970EUROPA™ Pedicle Screw SystemMiRus, LLC20192—
+3K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+3K181188EVEREST Spinal SystemK2m, Inc.20186—
+3K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+3K171838TiLock2 Spinal SystemGenesys Spine20174—
+3K163181TRANSLACE™ Spinal Tethering SystemMedtronic Sofamor Danek USA, Inc.20172—
+3K161332NILE Proximal Fixation Spinal SystemK2m, Inc.20175—
+3K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+3K162786PASS LP Spinal SystemMedicrea International SA20176—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+3K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+3K152132X-spine Pedicle Screw SystemX-Spine Systems, Inc.201511
+3K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+3K151216Everest Spinal SystemK2m, Inc.201511—
+3K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+3K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+3K130877Expedium Spine SystemMedos International SARL20138—
+3K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+3K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+3K122901Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix2012116—
+3K113058Tiger Spine SystemCorelink, LLC201281—
+3K120047Coral Spinal SystemTheken Spine, LLC201214—
+3K110551Expedium Spine SystemJohnson & Johnson20111—
+3K111183Ascent Posterior Occipital Thoracic (Poct) System (Titanium & Cobalt Chrome Rods)Orthofix, Inc.201122—
+3K102701Viper Spine SystemDepuy Spine, Inc.2010184—