510(k) K141383

ACUMED HAND FRACTURE SYSTEM by Acumed, LLC — Product Code HRS

K141383 is an FDA 510(k) premarket notification submitted by Acumed, LLC for the device "ACUMED HAND FRACTURE SYSTEM". The FDA issued a decision of Substantially Equivalent on June 13, 2014. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Acumed, LLC has at least 10 other 510(k) clearances on record.