510(k) K112218

ACE-FISCHER(R), TEMPFIX(R), HOFFMAN CLASSIC(TM) EXTERNAL FIXATORS by DePuy Orthopaedics, Inc. — Product Code KTT

K112218 is an FDA 510(k) premarket notification submitted by DePuy Orthopaedics, Inc. for the device "ACE-FISCHER(R), TEMPFIX(R), HOFFMAN CLASSIC(TM) EXTERNAL FIXATORS". The FDA issued a decision of Substantially Equivalent on December 15, 2011. 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. DePuy Orthopaedics, Inc. has at least 10 other 510(k) clearances on record.