510(k) Report

Devices descending from K003641

5 later devices reach Biolok Screw, Biosteon Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251680Biosteon® ScrewBiocomposites, Ltd.20260—
+1K081390Bioactif Osteotrans Interfence ScrewTakiron Co., Ltd.20080—
+1K050468Triabsorb Composite ScrewAdvanced Biomaterials20050—
+1K021351Biosteon Cross PinBiocomposites, Ltd.200211
+2K033792Bilok ST ScrewBiocomposites, Ltd.20040—