510(k) Report

Devices descending from K061002

44 later devices reach Maxima Anterior Cervical Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140234Aspiron Acp SystemU&I Corp.20146—
+1K131200Aspiron Acp SystemU&I Corporation20137—
+1K121862Rex Anterior Cervical Plate SystemDio Medical Co., Ltd.20127—
+1K121078Van Gogh Anterior Cervical Plate SystemAccel Spine20120—
+1K113509Lexus Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.201219—
+1K102265LDR Spine Usa C-Plate, TL Anterior Cervical Plate SystemLdr Spine USA20107—
+2K231251FlexWing Anterior Cervical Plate SystemJeil Medical Corporation20242—
+2K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+2K222572FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and…Dio Medical Corporation20222—
+2K190053SECULOK™ ACP SystemU&I Corporation20191—
+2K182055SECULOK™ ACP SystemU&I Corporation20182—
+2K173099Fortis and Hana Anterior Cervical Plate SystemHuvexel Co., Ltd.20174—
+2K153526Pyrenees Cervical Plate SystemK2m20166—
+2K143271CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.201515—
+2K143279LnK Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20155—
+2K132366Spinal Intervertebral Body Fixation OrthosisAccel Spine20130—
+2K131520Nexus Anterior Cervical Plate SystemCore-Nexus20130—
+3K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+3K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+3K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+3K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+3K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc.20250—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K231460FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System…K&J Consulting Corp.20230—
+3K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+3K220379IMPEACE and IMPEACE-Uni Anterior Cervical Plate SystemMedynus, Inc.20220—
+3K220147Aspiron S ACP SystemU&I Corporation20220—
+3K190425CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.201913—
+3K183073SMG Anterior Cervical Plate SystemSapphire Medical Group20190—
+3K181190Pinehurst Anterior Cervical Plate SystemSignature Orthopaedics Pty, Ltd.20190—
+3K162664Pyrenees Cervical Plate SystemK2m, Inc.20165—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+4K202878Prase-AP Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20211—
+4K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc.20184—
+5K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+5K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+5K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+5K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+5K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+5K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+6K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+6K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+6K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—