510(k) K163698

OptiFix Open Absorbable Fixation System - 20 absorbable fasteners by C.R. Bard, Inc. — Product Code GDW

K163698 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "OptiFix Open Absorbable Fixation System - 20 absorbable fasteners". The FDA issued a decision of Substantially Equivalent on Apr 11, 2017. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. C.R. Bard, Inc. has 645 other 510(k) clearances on record.