510(k) K954246

ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW by Acufex Microsurgical, Inc. — Product Code HWC

K954246 is an FDA 510(k) premarket notification submitted by Acufex Microsurgical, Inc. for the device "ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW". The FDA issued a decision of SN on February 15, 1996. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Acufex Microsurgical, Inc. has at least 10 other 510(k) clearances on record.