510(k) K212431

Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve by Biomet, Inc. — Product Code JDG

K212431 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve". The FDA issued a decision of Substantially Equivalent on February 7, 2022. The device falls under product code JDG (Prosthesis, Hip, Femoral Component, Cemented, Metal), a Class II device regulated under 21 CFR 888.3360. Biomet, Inc. has at least 10 other 510(k) clearances on record.