510(k) K063374

NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE by Grace Medical, Inc. — Product Code ETB

K063374 is an FDA 510(k) premarket notification submitted by Grace Medical, Inc. for the device "NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE". The FDA issued a decision of Substantially Equivalent on December 6, 2006. The device falls under product code ETB (Prosthesis, Partial Ossicular Replacement), a Class II device regulated under 21 CFR 874.3450. Grace Medical, Inc. has at least 10 other 510(k) clearances on record.