510(k) Report

Devices descending from K031175

928 later devices reach Click'x Monoaxial Screws and Hooks through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+1K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+1K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+1K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+1K120838Synthes Matrix SystemSynthes Spine201216—
+1K120928Synthes Matrix SystemSynthes Spine20120—
+1K120571Synthes Uss ConnectorSynthes Spine201274—
+1K113149Synthes Uss ConnectorsSynthes Spine201293—
+1K113044Synthes MirsSynthes Spine2011933
+1K111358Synthes UssSynthes Spine2011151—
+1K100634Synthes Matrix SystemSynthes (Usa)2010316—
+1K082914ClampfixSynthes Spine2008350—
+1K082572Uss Iliosacral, Uss PolyaxialSynthes Spine2008659—
+1K070973Quantum Spinal SystemPioneer Surgical Technology2007178—
+1K062670Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated200712—
+1K061342Malibu Spinal SystemSeaspine, Inc.2006801
+1K052151Synthes Pangea Monoaxial SystemSynthes Spine Co.Lp2005562—
+1K051942Malibu Spinal SystemSeaspine, Inc.20058111
+1K051663Malibu Spinal SystemSeaspine, Inc.200581—
+1K040442Protex Stabilization SystemGlobus Medical, Inc.2004551—
+2K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+2K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+2K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+2K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+2K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+2K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+2K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+2K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+2K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+2K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+2K200303Reform Pedicle Screw SystemPrecision Spine202010—
+2K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+2K190376PASS LP Spinal SystemMedicrea International SA201915
+2K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+2K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+2K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+2K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+2K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+2K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+2K180176SeaSpine NewPort Spinal SystemSeaSpine Orthopedics Corporation20180—
+2K173882SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation2018561
+2K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+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—
+2K170654USS SystemSynthes USA Products, LLC201789—
+2K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+2K161535SeaSpine® NewPort™ Spinal SystemSeaSpine Orthopedics Corporation201614—
+2K160902Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation201660—
+2K153404Zavation Spinal SystemZavation, LLC20161—
+2K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+2K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+2K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+2K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+2K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+2K141850Flospine Pedicle Screw SystemFlospine20140—
+2K142460EXPEDIUM Spine System/Synapse SystemJohnson and Johnson201401
+2K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+2K141044M.U.S.T. ExtensionMedacta International201416—
+2K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+2K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+2K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+2K122571Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc.201262—
+2K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+2K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+2K121568Dali Spinal Fixation SystemAccel Spine20121—
+2K121630Range Spinal SystemK2m, Inc.2012127—
+2K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+2K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+2K120291OP Spine SystemOrthoPediatrics Corp.2012138—
+2K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+2K120047Coral Spinal SystemTheken Spine, LLC201214—
+2K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+2K101790Quantum Spinal System, Quantum MisPioneer Surgical Technology201110—
+2K102870Exactech Proliant Polyaxial Pedicle Screw SystemExactech, Inc.20119—
+2K103287Synthes 6.0 Cocr and CPT TI-3 RodsSynthes Spine2011348—
+2K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+2K091445CD Horizon Spinal SystemMedtronic Sofamor Danek2010581—
+2K093692Quantum/ Streamline Spinal System Model 02-Series and 10-SeriesPioneer Surgical Technology201090—
+2K100952Modification to Synthes Matrix SystemSynthes Spine2010314Class I
+2K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088—
+2K100044Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone2010117—
+2K090605ClampfixSynthes (Usa)2009349—
+2K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+2K082797Blackstone Pedicle Screw SystemBlackstone Medical, Inc.2008209—
+2K081684Blackstone Pedicle Screw SystemBlackstone Medical, Inc.20082773
+2K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+2K080518Pioneer Surgical Technology Quantum Spinal SystemPioneer Surgical Technology2008174—
+2K080504Pioneer Lowtop Spinal Rod SystemPioneer Surgical Technology200892—
+2K073245Extended Vertiflex Spinal Screw SystemVertiflex, Inc.200810—
+2K073517H-Link Integrated RodGlobus Medical, Inc.20080—
+2K072605Malibu Spinal SystemSeaspine, Inc.200767—
+2K072187Pioneer Lowtop Spinal Rod SystemPioneer Surgical Technology2007177—
+2K061202Revere Stabilization SystemGlobus Medical, Inc.2006547—
+2K052069Protex Stabilization System with Additional ComponentesGlobus Medical, Inc.2005549—
+2K042953Modification to Protex Stabilization SystemGlobus Medical, Inc.20040—
+3K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+3K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—