510(k) Report

Devices descending from K052552

39 later devices reach Hybrid Anterior Cervical Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171439EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate…Medos International SARL20170—
+1K132324Skyline Anterior Cervical Plate System, Uniplate Anterior Cervical Plate System…Medos International SARL20133—
+1K130427Pioneer Aspect Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20135—
+1K103491Skyline Anterior Cervical Plate SystemA Johnson & Johnson Company201134—
+2K252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+2K222493CODA™ Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20221—
+2K220182Aggeris™-CClariance20221—
+2K200224SEA-LINK Anterior Cervical Plate SystemIndius Medical Technologies Pvt., Ltd.20200—
+2K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+2K183060CervAlign™ Anterior Cervical Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201921
+2K181244Zavation Cervical Plate SystemZavation Medical Products, LLC20187—
+2K172104Ozark (tm) Cervical Plate SystemK2m, Inc.20175—
+2K153526Pyrenees Cervical Plate SystemK2m20166—
+2K133245Genesys Spine Anterior Cervical Plate II SystemGenesys Spine201411
+2K123578Anterior Cervical Plate SystemWeigao Orthopaedic Device Co., Ltd.20130—
+2K123167Depuy Pulse Anterior Cervical in-Line Plate SystemMedos International SARL20120—
+2K121078Van Gogh Anterior Cervical Plate SystemAccel Spine20120—
+2K112861Sintea Plustek Anterior Cervical Plate SystemSintea Plustek, LLC20120—
+2K112724Depuy Pulse Anterior Cerical Plate SystemMedos International SARL20112—
+3K243904Elegance® Anterior Cervical plateClariance202501
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+3K230993CODA™ Anterior Cervical Plate SystemPioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech20230—
+3K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+3K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+3K211408CervAlign® Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20211—
+3K192076Binary® Anterior Cervical Plate SystemGenesys Spine20190—
+3K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc.20184—
+3K162664Pyrenees Cervical Plate SystemK2m, Inc.20165—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K251436Resolve Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20250—
+4K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+4K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+4K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+5K250769Dakota LP SystemPrecision Spine, Inc.20250—
+5K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+5K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+6K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+7K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—