510(k) Report

Devices descending from K133794

8 later devices reach 4.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord Suture… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173859HEALIX ADVANCE Anchor with DYNACORD SutureMedos International SARL20184—
+1K170639HEALIX ADVANCE Anchor with PERMATAPE SutureMedos International SARL20171—
+1K141259Gryphon BR Anchor with Permacord, Gryphon BR DS Anchor with Permacord,Gryphon Peek…Depuy Mitek, A Johnson & Johnson Company20141—
+2K200949HEALIX ADVANCE Anchor with DYNATAPE SutureMedos International SARL20201—
+2K191483HEALIX ADVANCE Anchor with DYNA+TAPE SuturesMedos International SARL20190—
+2K183506HEALIX ADVANCE Anchor with DYNACORD SutureMedos International SARL20192—
+2K181809GRYPHON® Anchors with DYNACORD™ SutureMedos International SARL20180—
+3K203794HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE SutureMedos International SARL20210—