510(k) Report

Devices descending from K970549

26 later devices reach Titanium Alloy Bone Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142707AIS Odontoid Fracture Fixation SystemAesculap Implant System, Inc.20143—
+1K023365Leforte System Bone ScrewJeil Medical Corporation200320—
+1K994382Nonlinear Taper Lag ScrewTheken Surgical20000—
+2K192744CORRIDOR Fixation SystemGlobus Medical, Inc.20192—
+2K132876Arix Hand Locking SystemJeil Medical Corporation20130—
+2K131311Arix Foot SystemJeil Medical Corporation20139—
+2K050669Jeil Bone Fixation SystemJeil Medical Corporation20058—
+3K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+3K192417ARIX Cannulated Screw SystemJeil Medical Corporation20191—
+3K182881Bone Screw, Bone TackOsstem Implant Co., Ltd.20191—
+3K170697GBR systemSurgident20182—
+3K170780ARIX Foot System (2.3/2.8)Jeil Medical Corporation20174—
+3K161864ARIX Foot SystemJeil Medical Corporation20165—
+3K143730GBR SystemJeil Medical Corporation20152—
+4K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+4K251569Bone ScrewOsstem Implant Co., Ltd.20250—
+4K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+4K222367Save GBRDentis Co., Ltd.20230—
+4K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+4K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+4K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.20200—
+4K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+4K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+4K160991Neo GBR SystemNeobiotech Co., Ltd.20171—
+5K192592Axis Plating SystemExtremity Medical, LLC20190—
+5K181854OssBuilder SystemOsstem Implant Co., Ltd.20190—