510(k) K911338

LIMA CEMENT RESTRICTOR by Turnkey Intergration USA, Inc. — Product Code JDK

K911338 is an FDA 510(k) premarket notification submitted by Turnkey Intergration USA, Inc. for the device "LIMA CEMENT RESTRICTOR". The FDA issued a decision of Substantially Equivalent on June 28, 1991. The device falls under product code JDK (Prosthesis, Hip, Cement Restrictor), a Class II device regulated under 21 CFR 878.3300. Turnkey Intergration USA, Inc. has at least 10 other 510(k) clearances on record.