510(k) K101086

TAPERLOC COMPLETE by Biomet, Inc. — Product Code KWA

K101086 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "TAPERLOC COMPLETE". The FDA issued a decision of Substantially Equivalent on September 3, 2010. The device falls under product code KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)), a Class III device regulated under 21 CFR 888.3330. Biomet, Inc. has at least 10 other 510(k) clearances on record.