510(k) Report

Devices descending from K160304

8 later devices reach OsteoBullet Compression Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc.20250—
+1K200291CREED™ Cannulated ScrewsGlw Medical, Inc.20202—
+1K180257InCore® Lapidus SystemNextremity Solutions, Inc.20183—
+2K223847CREED™ Cannulated ScrewsGlw, Inc.20230—
+2K221489Artemis Proximal Femoral Nail SystemGlw, Inc.20220—
+2K200124InCore MPJ SystemNextremity Solutions, Inc.20200—
+2K192578InCore TMT SystemNextremity Solutions, Inc.20191—
+2K190231InCore® Lapidus Sterile KitsNextremity Solutions, Inc.20190—