510(k) K953653

LUBINUS SP II HIP SYSTEM by Turnkey Intergration USA, Inc. — Product Code JDG

K953653 is an FDA 510(k) premarket notification submitted by Turnkey Intergration USA, Inc. for the device "LUBINUS SP II HIP SYSTEM". The FDA issued a decision of Substantially Equivalent on November 6, 1995. The device falls under product code JDG (Prosthesis, Hip, Femoral Component, Cemented, Metal), a Class II device regulated under 21 CFR 888.3360. Turnkey Intergration USA, Inc. has at least 10 other 510(k) clearances on record.