510(k) K822632

ELBOW PROSTHESIS by Hosmer Dorrance Corp. — Product Code IRE

K822632 is an FDA 510(k) premarket notification submitted by Hosmer Dorrance Corp. for the device "ELBOW PROSTHESIS". The FDA issued a decision of Substantially Equivalent on September 14, 1982. The device falls under product code IRE (Joint, Elbow, External Limb Component, Powered), a Class I device regulated under 21 CFR 890.3420. Hosmer Dorrance Corp. has at least 8 other 510(k) clearances on record.