510(k) K872715

UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY by Roseburg SA — Product Code JDN

K872715 is an FDA 510(k) premarket notification submitted by Roseburg SA for the device "UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY". The FDA issued a decision of SN on December 7, 1987. The device falls under product code JDN (Implant, Fixation Device, Spinal), a Class II device regulated under 21 CFR 888.3060. Roseburg SA has at least 10 other 510(k) clearances on record.