510(k) Report

Devices descending from K162996

2 later devices reach INVISIKNOT Ankle Syndesmosis Repair Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242091Bolo Button SystemFusion Orthopedics20240—
+1K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company20240—