510(k) K050492

INTEGRA BONE FIXATION SYSTEM by Integra Lifesciences Corp. — Product Code HRS

K050492 is an FDA 510(k) premarket notification submitted by Integra Lifesciences Corp. for the device "INTEGRA BONE FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on March 14, 2005. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Integra Lifesciences Corp. has at least 10 other 510(k) clearances on record.