510(k) Report

Devices descending from K162805

5 later devices reach Akros Fibulink Syndesmosis Repair Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173550Akros FibuLink™ Syndesmosis Repair KitAkros Medical20174—
+2K211770R3ACT Stabilization SystemParagon 28, Inc.20213—
+3K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+4K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+5K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—