510(k) K050699

MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004 by Amedica Corp. — Product Code JDK

K050699 is an FDA 510(k) premarket notification submitted by Amedica Corp. for the device "MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004". The FDA issued a decision of Substantially Equivalent on April 15, 2005. The device falls under product code JDK (Prosthesis, Hip, Cement Restrictor), a Class II device regulated under 21 CFR 878.3300. Amedica Corp. has at least 10 other 510(k) clearances on record.