510(k) Report

Devices descending from K960914

13 later devices reach 3I Osseous Fixation System (S) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K011698Straumann GBR SystemInstitut Straumann AG200112—
+2K233419GBR SystemProimtech Saglik Urunleri Anonim Sirketi20250—
+2K182881Bone Screw, Bone TackOsstem Implant Co., Ltd.20191—
+2K063769Alpha Bio Bone Fixation Screw SystemAlpha-Bio Tec, Ltd.20074—
+2K050669Jeil Bone Fixation SystemJeil Medical Corporation20058—
+3K251569Bone ScrewOsstem Implant Co., Ltd.20250—
+3K170697GBR systemSurgident20182—
+3K143730GBR SystemJeil Medical Corporation20152—
+3K141764Tristar Bone Graft Fixation SystemImpladent, Ltd.20143—
+4K222367Save GBRDentis Co., Ltd.20230—
+4K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.20200—
+4K160991Neo GBR SystemNeobiotech Co., Ltd.20171—
+5K181854OssBuilder SystemOsstem Implant Co., Ltd.20190—