510(k) Report

Devices descending from K173550

4 later devices reach Akros FibuLink™ Syndesmosis Repair Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211770R3ACT Stabilization SystemParagon 28, Inc.20213—
+2K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+3K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+4K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—