510(k) Report

Devices descending from K080792

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K180376K2M Patient Specific RodsK2m, Inc.20182—
+3K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+3K171321K2M Navigation InstrumentsK2m201711
+3K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+3K171838TiLock2 Spinal SystemGenesys Spine20174—
+3K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+3K163181TRANSLACE™ Spinal Tethering SystemMedtronic Sofamor Danek USA, Inc.20172—
+3K170647Connector SystemOrthofix, Inc.201718—
+3K161332NILE Proximal Fixation Spinal SystemK2m, Inc.20175—
+3K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+3K162786PASS LP Spinal SystemMedicrea International SA20176—
+3K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+3K161369EVEREST Spinal SystemK2m, Incorporated20169—
+3K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+3K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+3K152132X-spine Pedicle Screw SystemX-Spine Systems, Inc.201511
+3K151216Everest Spinal SystemK2m, Inc.201511—
+3K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+3K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+3K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+3K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+3K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+3K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+3K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+3K131833Centurion Poct SystemOrthofix, Inc.20142—
+3K133103Aversion Pedicle Screw SystemK7, LLC20140—
+3K133369Tiger Spine SystemCorelink, LLC201429—
+3K131250Tiger Spine SystemCorelink, LLC201340—
+3K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+3K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+3K131343Reform Pedicle Screw SystemSpinal USA201331—
+3K130279Reform Pedicle Screw SystemSpinal USA201331—
+3K130176Firebird Spinal Fixation SystemOrthofix20135—
+3K123939S4 Spinal SystemAesculap Implant Systems, Inc.20133—
+3K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+3K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+3K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+3K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—
+3K120564Calypso SystemHogan Lovells US LLP201216—
+3K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+3K121020Viper SystemDepuy Spine, Inc.201294—
+3K113058Tiger Spine SystemCorelink, LLC201281—
+3K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226—
+3K113044Synthes MirsSynthes Spine2011933
+3K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+3K111957Polaris Spinal SystemBiomet Spine (Ebi, LLC)201176—
+3K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+3K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+3K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+3K100845Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500 SeriesZimmer Spine, Inc.201045
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+4K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+4K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+4K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+4K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+4K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+4K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K240963Spinal SystemTeslake, Inc.20240—
+4K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+4K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+4K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+4K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+4K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+4K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+4K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+4K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+4K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+4K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+4K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+4K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+4K201006K2M Navigation InstrumentsK2m, Inc.20200—
+4K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+4K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+4K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+4K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+4K192680Percusys® Plus Pedicle Screw SystemJoimax GmbH20190—
+4K193219G Surgical Marksman SystemG Surgical, LLC20191—
+4K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+4K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+4K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+4K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+4K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+4K182240PASS LP Spinal SystemMedicrea International SA20182—