510(k) K153622

First Ray Internal Bone Staple System by First Ray, LLC — Product Code JDR

K153622 is an FDA 510(k) premarket notification submitted by First Ray, LLC for the device "First Ray Internal Bone Staple System". The FDA issued a decision of Substantially Equivalent on Apr 8, 2016. The device falls under product code JDR (Staple, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. First Ray, LLC has 3 other 510(k) clearances on record.