510(k) K042778

BIOANCHOR WITH DISPOSABLE DRIVER, PRELOADED WITH ONE #2 HERCULINE SUTURE by Linvatec Corp. — Product Code HWC

K042778 is an FDA 510(k) premarket notification submitted by Linvatec Corp. for the device "BIOANCHOR WITH DISPOSABLE DRIVER, PRELOADED WITH ONE #2 HERCULINE SUTURE". The FDA issued a decision of Substantially Equivalent on November 4, 2004. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Linvatec Corp. has at least 10 other 510(k) clearances on record.