510(k) Report

Devices descending from K133757

16 later devices reach GFS II Standard, GFS II Large, GFS Mimi through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…Parcus Medical, LLC20202—
+1K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC20203—
+1K183331Parcus GFS BTBParcus Medical, LLC20193—
+1K160655OrthoButton CLRiverpoint Medical20169—
+1K152711Parcus GFS NakedParcus Medical, LLC20154—
+2K213018Auxilock GFS Mini, GFS II Large, and GFS UltimateAuxein Medical Private Limited20220—
+2K212739ActiFlipParcus Medical, LLC20210—
+2K191319Dunamis Fixation Button SystemDunamis, LLC20191—
+2K171060OrthoButton ALRiverpoint Medical20178—
+3K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+3K240835Suture Button Repair SystemSkeletal Dynamics, Inc.20241—
+3K240194ProCinch, QuadCinchRiverpoint Medical20240—
+3K233552IDEAL ZiploopRiverpoint Medical20230—
+3K230212OrthoButton ALRiverpoint Medical, LLC20232—
+3K202399OrthoButton FLRiverpoint Medical20201—
+4K261770Suture Button Repair SystemSkeletal Dynamics, Inc.20260—