510(k) K954517

TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT & STRAIGHT INCUS STRUT by Trebay Medical Corp. — Product Code ETB

K954517 is an FDA 510(k) premarket notification submitted by Trebay Medical Corp. for the device "TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT & STRAIGHT INCUS STRUT". The FDA issued a decision of Substantially Equivalent on October 27, 1995. The device falls under product code ETB (Prosthesis, Partial Ossicular Replacement), a Class II device regulated under 21 CFR 874.3450. Trebay Medical Corp. has at least 10 other 510(k) clearances on record.