510(k) Report

Devices descending from K082396

13 later devices reach Davol Absorbable Fastener System, Model (S) 0113080,0113081, 0113082, 0113084… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201934Surgimatix Absorbable Fixation SystemSurgimatix, Inc.20210—
+1K132134Optifix Absorbable Fixation SystemC.R. Bard, Inc.20134—
+1K111153Sorbafix (TM) Absorbable Fixation System, Permafix (TM) Fixation SystemC.R. Bard, Inc.20111—
+1K092483Bard Permafix Fixation System, Model 0113012, 0113014, 0113016, 0116018C.R. Bard, Inc.20096—
+2K142873OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix…C.R. Bard, Inc.20153—
+2K132698Fastouch Fixation SystemVia Surgical, Ltd.20143—
+2K123718Permasorb Disposable Fixation DeviceC.R. Bard, Inc.20130—
+3K181668FasTouch Absorbable Fixation SystemVia Surgical, Ltd.20191—
+3K170278OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners…C.R. Bard, Inc.20171—
+3K163698OptiFix Open Absorbable Fixation System - 20 absorbable fastenersC.R. Bard, Inc.20170—
+3K162252FasTouch Fixation SystemVia Surgical, Ltd.20162—
+4K203117TissueTak deviceVia Surgical, Ltd.20210—
+4K191287OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners…Davol Inc., Subsidiary of C.R. Bard20190—