510(k) Report

Devices descending from K023365

20 later devices reach Leforte System Bone Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132876Arix Hand Locking SystemJeil Medical Corporation20130—
+1K131311Arix Foot SystemJeil Medical Corporation20139—
+1K050669Jeil Bone Fixation SystemJeil Medical Corporation20058—
+2K192417ARIX Cannulated Screw SystemJeil Medical Corporation20191—
+2K182881Bone Screw, Bone TackOsstem Implant Co., Ltd.20191—
+2K170697GBR systemSurgident20182—
+2K170780ARIX Foot System (2.3/2.8)Jeil Medical Corporation20174—
+2K161864ARIX Foot SystemJeil Medical Corporation20165—
+2K143730GBR SystemJeil Medical Corporation20152—
+3K251569Bone ScrewOsstem Implant Co., Ltd.20250—
+3K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+3K222367Save GBRDentis Co., Ltd.20230—
+3K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+3K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+3K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.20200—
+3K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+3K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+3K160991Neo GBR SystemNeobiotech Co., Ltd.20171—
+4K192592Axis Plating SystemExtremity Medical, LLC20190—
+4K181854OssBuilder SystemOsstem Implant Co., Ltd.20190—