510(k) Report

Devices descending from K971883

531 later devices reach Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc.20191—
+1K150983Pyrenees Cervical Plate SystemK2m20157—
+1K141500Optio-C Anterior Cervical SystemZimmer Spine, Inc.20142—
+1K131512Katia SystemShanghai Sanyou Medical Co, Ltd.20131—
+1K130427Pioneer Aspect Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20135—
+1K111796Invizia Anterior Cervical Plate SystemZimmer Spine, Inc.201118—
+1K111135Pyrenees Cervical Plate System (Translational Plates)K2m, Inc.20111—
+1K103287Synthes 6.0 Cocr and CPT TI-3 RodsSynthes Spine2011348—
+1K092474Pyrenees Cervical Plate System, Semi-Constrained ScrewsK2m, Inc.20108—
+1K063544Modification to Pyrenees Cervical Plate SystemK2m, Inc.200738—
+1K051815Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc.200510—
+1K051665Synthes Vectra-T SystemSynthes Spine2005492
+1K043066Pioneer Anterior Cervical Plate SystemPioneer Surgical Technology200527—
+1K030595Blackstone Fusion Anterior Cervical Plating SystemBlackstone Medical, Inc.200366—
+1K022344Trinica Select Anterior Cervical Plate SystemCenterpulse Spine-Tech, Inc.2002431
+1K012184Blackstone Iii Anterior Cervical Plating SystemBlackstone Medical, Inc.200285—
+2K240592Wolff's Law Anterior Cervical Plate SystemSpinal Simplicity, LLC20240—
+2K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+2K2117123° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity…Orthofix US, LLC20220—
+2K213901Cyclops™ Anterior Cervical Plate SystemDegen Medical20220—
+2K210182PANAMA™ Anterior Cervical Plate (ACP) SystemFlospine20210—
+2K200927Transept Cervical Plate SystemNeurostructures, Inc.20200—
+2K200523Biolign® Roto-Loc Cervical Plate SystemElite Surgical Supplies (Pty), Ltd.20200—
+2K183060CervAlign™ Anterior Cervical Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201921
+2K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+2K170654USS SystemSynthes USA Products, LLC201789—
+2K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc.20163—
+2K162664Pyrenees Cervical Plate SystemK2m, Inc.20165—
+2K153526Pyrenees Cervical Plate SystemK2m20166—
+2K152239Zero-P Natural Plate SystemSynthes (Usa), LLC20150—
+2K152281Pyrenees Cervical Plate SystemK2m20156—
+2K152015Pyrenees Cervical Plate SystemK2m, Inc.20150—
+2K142212Pyrenees Cervical Plate SystemK2m, Inc.20150—
+2K143626inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating…Zimmer Spine, Inc.201516—
+2K142060Transom Anterior Cervical PlateNeurostructures, Inc.201419—
+2K133245Genesys Spine Anterior Cervical Plate II SystemGenesys Spine201411
+2K140234Aspiron Acp SystemU&I Corp.20146—
+2K132310ASCOTBackroads Consulting, Inc.20130—
+2K131200Aspiron Acp SystemU&I Corporation20137—
+2K132012Trinica (R) Anterior Cervical Plate System, Trinica (R) Select Anterior Cervical Plate…Zimmer Spine, Inc.201322—
+2K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+2K122497Asfora Anterior Cervical Plate System, One Level, 14MM Asfora Anterior Cervical Plate…Medical Design, LLC20121—
+2K121049Unify Dynamic Anterior Cervical Plate SystemGlobus Medical, Inc.201210—
+2K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+2K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+2K113361Securis Spinal FixationCumtom Spine20120—
+2K113149Synthes Uss ConnectorsSynthes Spine201293—
+2K113329K2M, Pyrenees Cervical Plate SystemK2m, Inc.201228—
+2K113044Synthes MirsSynthes Spine2011933
+2K111358Synthes UssSynthes Spine2011151—
+2K112068Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp2011331
+2K100708Pioneer Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology201012—
+2K083663PACPPioneer Surgical Technology200917—
+2K073500Active Anterior Cervical Plate SystemSanacor20080—
+2K081567Vertebron SSP Cervical Plating SystemVertebron, Inc.20086—
+2K073530Accin Anterior Cervical Plate SystemAccelerated Innovation, LLC20083—
+2K062110Vertebron SCP Cervical Plate SystemVertebron, Inc.20069—
+2K053053Pacp SystemPioneer Surgical Technology200525—
+2K050892Hallmarktm Anterior Cervical Plate SystemBlackstone Medical, Inc.2005522
+2K040003Vertebron SCP Cervical Plate SystemVertebron, Inc.200412—
+2K031214Cyclone Anterior Cervical Plate SystemEncore Medical L.P.2003132
+2K022965Blackstone Classic Anterior Cervical PlateBlackstone Medical, Inc.200310—
+2K020620Blackstone Iii Degree Anterior Cervical Plating System (Plate Washer)Blackstone Medical, Inc.20021—
+2K020600Blackstone Iii Anterior Cervical Plating System (Plate Washer)Blackstone Medical, Inc.20020—
+3K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+3K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+3K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+3K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+3K231251FlexWing Anterior Cervical Plate SystemJeil Medical Corporation20242—
+3K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+3K240935ARENAL Anterior Cervical Plate SystemEffortmed, LLC20240—
+3K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+3K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+3K223321Omnia Medical Coupler-C Anterior Cervical PlateOmnia Medical, LLC20230—
+3K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+3K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+3K211408CervAlign® Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20211—
+3K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+3K192481AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.202013—
+3K192314RESONATE Anterior Cervical Plate SystemGlobus Medical, Inc.20193—
+3K192076Binary® Anterior Cervical Plate SystemGenesys Spine20190—
+3K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+3K190376PASS LP Spinal SystemMedicrea International SA201915
+3K183409Athena II Cervical Plate SystemMedyssey USA, Inc.20191—
+3K190053SECULOK™ ACP SystemU&I Corporation20191—
+3K181190Pinehurst Anterior Cervical Plate SystemSignature Orthopaedics Pty, Ltd.20190—
+3K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc.20184—
+3K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+3K182055SECULOK™ ACP SystemU&I Corporation20182—
+3K180022Athena Cervical Plate SystemMedyssey USA, Inc.20182—
+3K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+3K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+3K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+3K173521SeaSpine Cabo ACP (Anterior Cervical Plate) SystemSeaSpine Orthopedics Corporation201815—
+3K172585Liberty Anterior Cervical PlateValorus Spine20170—
+3K172104Ozark (tm) Cervical Plate SystemK2m, Inc.20175—
+3K171112Trifore (tm) Cervical Plating SystemNeurostructures, Inc.20171—