510(k) K050227

THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER by Linvatec Corp. — Product Code MBI

K050227 is an FDA 510(k) premarket notification submitted by Linvatec Corp. for the device "THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER". The FDA issued a decision of Substantially Equivalent on March 2, 2005. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Linvatec Corp. has at least 10 other 510(k) clearances on record.