510(k) K041583

PEEK CEMENT RESTRICTOR X-BOX by Innovasis, Inc. — Product Code JDK

K041583 is an FDA 510(k) premarket notification submitted by Innovasis, Inc. for the device "PEEK CEMENT RESTRICTOR X-BOX". The FDA issued a decision of SESU on July 22, 2004. The device falls under product code JDK (Prosthesis, Hip, Cement Restrictor), a Class II device regulated under 21 CFR 878.3300. Innovasis, Inc. has at least 10 other 510(k) clearances on record.