510(k) K922645

LSF ANATOMIC CEMENTED HIP by Osteo Technology, Inc. — Product Code JDI

K922645 is an FDA 510(k) premarket notification submitted by Osteo Technology, Inc. for the device "LSF ANATOMIC CEMENTED HIP". The FDA issued a decision of Substantially Equivalent on January 7, 1993. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Osteo Technology, Inc. has at least 10 other 510(k) clearances on record.