510(k) K140617

PINIT SMALL BONE FUSION SYSTEM by Arthrosurface, Inc. — Product Code HRS

K140617 is an FDA 510(k) premarket notification submitted by Arthrosurface, Inc. for the device "PINIT SMALL BONE FUSION SYSTEM". The FDA issued a decision of Substantially Equivalent on April 25, 2014. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Arthrosurface, Inc. has at least 10 other 510(k) clearances on record.