510(k) K060132

SPINAL USA CEMENT RESTRICTOR SYSTEM by Spinal USA — Product Code JDK

K060132 is an FDA 510(k) premarket notification submitted by Spinal USA for the device "SPINAL USA CEMENT RESTRICTOR SYSTEM". The FDA issued a decision of Substantially Equivalent on March 16, 2006. The device falls under product code JDK (Prosthesis, Hip, Cement Restrictor), a Class II device regulated under 21 CFR 878.3300. Spinal USA has at least 10 other 510(k) clearances on record.