510(k) K925447

OTI ORTHOPEDIC WIRE SYSTEM by Osteo Technology, Inc. — Product Code JDQ

K925447 is an FDA 510(k) premarket notification submitted by Osteo Technology, Inc. for the device "OTI ORTHOPEDIC WIRE SYSTEM". The FDA issued a decision of Substantially Equivalent on June 29, 1993. The device falls under product code JDQ (Cerclage, Fixation), a Class II device regulated under 21 CFR 888.3010. Osteo Technology, Inc. has at least 10 other 510(k) clearances on record.