510(k) K080408

EXTERNAL FIXATION CLAMP 5.0 MM PIN X9.5MM ROD, MODEL 1151-100, EXTERNAL FIXATON CLAMP, 9.5MM ROD by Advanced Orthopaedic Solutions, Inc. — Product Code KTT

K080408 is an FDA 510(k) premarket notification submitted by Advanced Orthopaedic Solutions, Inc. for the device "EXTERNAL FIXATION CLAMP 5.0 MM PIN X9.5MM ROD, MODEL 1151-100, EXTERNAL FIXATON CLAMP, 9.5MM ROD". The FDA issued a decision of Substantially Equivalent on April 25, 2008. The device falls under product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component), a Class II device regulated under 21 CFR 888.3030. Advanced Orthopaedic Solutions, Inc. has at least 10 other 510(k) clearances on record.