510(k) K001353

MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM by Biomedical Ent., Inc. — Product Code HBW

K001353 is an FDA 510(k) premarket notification submitted by Biomedical Ent., Inc. for the device "MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM". The FDA issued a decision of Substantially Equivalent on March 13, 2001. The device falls under product code HBW (Fastener, Plate, Cranioplasty), a Class II device regulated under 21 CFR 882.5360. Biomedical Ent., Inc. has at least 10 other 510(k) clearances on record.