510(k) Report

Devices descending from K082572

659 later devices reach Uss Iliosacral, Uss Polyaxial through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+1K170654USS SystemSynthes USA Products, LLC201789—
+1K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+1K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+1K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+1K121568Dali Spinal Fixation SystemAccel Spine20121—
+1K121630Range Spinal SystemK2m, Inc.2012127—
+1K120838Synthes Matrix SystemSynthes Spine201216—
+1K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+1K120928Synthes Matrix SystemSynthes Spine20120—
+1K120571Synthes Uss ConnectorSynthes Spine201274—
+1K120291OP Spine SystemOrthoPediatrics Corp.2012138—
+1K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+1K113149Synthes Uss ConnectorsSynthes Spine201293—
+1K113044Synthes MirsSynthes Spine2011933
+1K111358Synthes UssSynthes Spine2011151—
+1K103287Synthes 6.0 Cocr and CPT TI-3 RodsSynthes Spine2011348—
+1K091445CD Horizon Spinal SystemMedtronic Sofamor Danek2010581—
+1K100952Modification to Synthes Matrix SystemSynthes Spine2010314Class I
+1K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088—
+1K100634Synthes Matrix SystemSynthes (Usa)2010316—
+1K100044Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone2010117—
+2K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+2K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+2K232561Ripley Spinal Screw System by SAGICOSagico VA USA, LLC20230—
+2K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+2K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+2K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+2K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+2K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+2K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+2K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+2K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+2K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+2K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+2K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+2K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+2K180220SAGICO OSI Spinal System by OsimplantSpinal Analytics & Geometrical Implant Co, LLC20181—
+2K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+2K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+2K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+2K173508Everest Spinal SystemK2m20189—
+2K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+2K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+2K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+2K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+2K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+2K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+2K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+2K161028K2M Growing Spine SystemK2m, Inc.20163—
+2K153404Zavation Spinal SystemZavation, LLC20161—
+2K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+2K151974Polaris Spinal SystemBiomet Spine201516—
+2K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+2K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+2K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+2K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+2K150600Response 5.5/6.0 Spine SystemOrthoPediatrics Corp.2015163
+2K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+2K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+2K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+2K141850Flospine Pedicle Screw SystemFlospine20140—
+2K142460EXPEDIUM Spine System/Synapse SystemJohnson and Johnson201401
+2K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+2K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+2K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+2K141044M.U.S.T. ExtensionMedacta International201416—
+2K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+2K141147Range Spinal SystemK2m, Inc.20141—
+2K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+2K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+2K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+2K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+2K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+2K132878M.U.S.T. ExtensionMedacta International201328—
+2K132757Everest Spinal SystemK2m, Inc.201341—
+2K132303Implanet Spine SystemImplanet, S.A.201315—
+2K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+2K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+2K131784Range Spinal SystemK2m, Inc.201334—
+2K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+2K130438Axle Interspinous Fusion SystemX-Spine Systems, Inc.2013181
+2K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+2K130655Response Spine SystemOrthoPediatrics Corp.201317—
+2K122877Range Spinal System, Small StatureK2m, Inc.201334—
+2K130330Range Spinal SystemK2m, Inc.201336—
+2K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+2K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+2K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+2K123134Easyspine SystemLdr Spine USA, Inc.20131—
+2K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+2K122901Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix2012116—
+2K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+2K113666Xia 3 Spinal SystemStryker Spine2012251—
+2K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+2K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+2K121250OP Spine SystemOrthoPediatrics Corp.201218—
+2K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+2K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+2K113361Securis Spinal FixationCumtom Spine20120—