510(k) K051069

NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER by Arthrotek, Inc. — Product Code MBI

K051069 is an FDA 510(k) premarket notification submitted by Arthrotek, Inc. for the device "NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER". The FDA issued a decision of Substantially Equivalent on June 29, 2005. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Arthrotek, Inc. has at least 10 other 510(k) clearances on record.