510(k) K100469

ARCOS INTERLOCKING DISTAL STEMS by Biomet Manufacturing Corp — Product Code KWA

K100469 is an FDA 510(k) premarket notification submitted by Biomet Manufacturing Corp for the device "ARCOS INTERLOCKING DISTAL STEMS". The FDA issued a decision of Substantially Equivalent on December 7, 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 Manufacturing Corp has at least 10 other 510(k) clearances on record.