510(k) K131845

ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC by Acumed, LLC — Product Code KWI

K131845 is an FDA 510(k) premarket notification submitted by Acumed, LLC for the device "ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC". The FDA issued a decision of Substantially Equivalent on September 30, 2013. The device falls under product code KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer), a Class II device regulated under 21 CFR 888.3170. Acumed, LLC has at least 10 other 510(k) clearances on record.