510(k) Report

Devices descending from K112643

26 later devices reach Focus Mis System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+1K143110GALAXY MIS Screw SystemBm Korea20152—
+1K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—
+1K120140Focus Spinal SystemL&K BIOMED Co., Ltd.201225—
+2K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+2K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+2K161766PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.201618—
+2K140219Picasso II Mis Spinal SystemAccel Spine20141—
+3K230762EDEN Spinal Fixation MIS SystemJmt Co., Ltd.20230—
+3K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+3K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+3K183117PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.20184—
+3K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+4K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.20260—
+4K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+4K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+4K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+4K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+4K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+4K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+5K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+5K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+6K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+6K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—