510(k) K812687

BRIGHAM II TOTAL HIP SYSTEM by Hexcel Medical — Product Code JDG

K812687 is an FDA 510(k) premarket notification submitted by Hexcel Medical for the device "BRIGHAM II TOTAL HIP SYSTEM". The FDA issued a decision of Substantially Equivalent on October 2, 1981. The device falls under product code JDG (Prosthesis, Hip, Femoral Component, Cemented, Metal), a Class II device regulated under 21 CFR 888.3360. Hexcel Medical has at least 10 other 510(k) clearances on record.