510(k) K001354

MEMOGRAPH; OSSTAPLE - ORTHOPEDIC USES FOR SMALL BONE AND FRAGMENT FIXATION FOR THE MEMOGRAPH STAPLE SYSTEM by Biomedical Ent., Inc. — Product Code JDR

K001354 is an FDA 510(k) premarket notification submitted by Biomedical Ent., Inc. for the device "MEMOGRAPH; OSSTAPLE - ORTHOPEDIC USES FOR SMALL BONE AND FRAGMENT FIXATION FOR THE MEMOGRAPH STAPLE SYSTEM". The FDA issued a decision of Substantially Equivalent on March 13, 2001. The device falls under product code JDR (Staple, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Biomedical Ent., Inc. has at least 10 other 510(k) clearances on record.