510(k) Report

Devices descending from K012305

70 later devices reach Modification to: Trinica Anterior Cervical Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141500Optio-C Anterior Cervical SystemZimmer Spine, Inc.20142—
+1K132012Trinica (R) Anterior Cervical Plate System, Trinica (R) Select Anterior Cervical Plate…Zimmer Spine, Inc.201322—
+1K120515Tempus Cervical Plate SystemNeurostructures, LLC201223—
+1K022344Trinica Select Anterior Cervical Plate SystemCenterpulse Spine-Tech, Inc.2002431
+2K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+2K210182PANAMA™ Anterior Cervical Plate (ACP) SystemFlospine20210—
+2K200927Transept Cervical Plate SystemNeurostructures, Inc.20200—
+2K171112Trifore (tm) Cervical Plating SystemNeurostructures, Inc.20171—
+2K160702ZION Anterior Cervical Fixation SystemAstura Medical20163—
+2K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+2K152239Zero-P Natural Plate SystemSynthes (Usa), LLC20150—
+2K143626inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating…Zimmer Spine, Inc.201516—
+2K142060Transom Anterior Cervical PlateNeurostructures, Inc.201419—
+2K131374Tempus (TM) Cervical Plate SystemNeurostructures, LLC201322—
+2K122497Asfora Anterior Cervical Plate System, One Level, 14MM Asfora Anterior Cervical Plate…Medical Design, LLC20121—
+2K111796Invizia Anterior Cervical Plate SystemZimmer Spine, Inc.201118—
+2K040003Vertebron SCP Cervical Plate SystemVertebron, Inc.200412—
+2K031214Cyclone Anterior Cervical Plate SystemEncore Medical L.P.2003132
+3K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc.20250—
+3K240592Wolff's Law Anterior Cervical Plate SystemSpinal Simplicity, LLC20240—
+3K223321Omnia Medical Coupler-C Anterior Cervical PlateOmnia Medical, LLC20230—
+3K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+3K213456Xenco Medical Multilevel CerviKitXenco Medical, LLC20210—
+3K192481AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.202013—
+3K200995Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc.2020729
+3K193494Origin™ Anterior Cervical Plate SystemOrthopaedic & Spine Development20200—
+3K192494NexGen Anterior Cervical Plate SystemPrecision Spine20190—
+3K173521SeaSpine Cabo ACP (Anterior Cervical Plate) SystemSeaSpine Orthopedics Corporation201815—
+3K163061Altus Spine Cervical Plate SystemAltus Partners, LLC20171—
+3K143688Asfora Anterior Cervical Plate SystemMedical Designs, LLC20150—
+3K091396Cardo Medical Anterior Cervical Plate SystemCardo Medical Corp.20092—
+3K081567Vertebron SSP Cervical Plating SystemVertebron, Inc.20086—
+3K073530Accin Anterior Cervical Plate SystemAccelerated Innovation, LLC20083—
+3K051815Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc.200510—
+3K043181Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc.200411—
+3K040397Modification to Cyclone Anterior Cervical Plate SystemEncore Medical L.P.2004032
+4K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+4K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+4K220843OAKTREE Anterior Lumbar Plate and Screw SystemOak Tree Engineering, LLC20220—
+4K213443Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc.20216—
+4K212139Admiral ACP SystemSeaSpine Orthopedics Corporation20216—
+4K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+4K211932Fixxsure Anterior Lumbar Plate and Screw SystemOak Tree Engineering, LLC20211—
+4K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+4K202064Admiral ACP SystemSeaSpine Orthopedics Corporation202014—
+4K183084Fuji Cervical Plate SystemAltus Partners, LLC20190—
+4K183409Athena II Cervical Plate SystemMedyssey USA, Inc.20191—
+4K180022Athena Cervical Plate SystemMedyssey USA, Inc.20182—
+4K132310ASCOTBackroads Consulting, Inc.20130—
+4K062110Vertebron SCP Cervical Plate SystemVertebron, Inc.20069—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+5K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+5K254182AsterOsteonic Co., Ltd.20260—
+5K252611aprevo® cervical plating systemCarlsmed, Inc.20253—
+5K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+5K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+5K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+5K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+5K230301Athena III Cervical Plate SystemMedyssey USA, Inc.20230—
+5K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+5K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K260570corra™ cervical plating systemCarlsmed, Inc.20261—
+6K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+6K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+6K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+7K262149corra® cervical plating systemCarlsmed, Inc.20260—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+7K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—