510(k) K060535

SPACER-S TEMPORARY SHOULDER SPACER by Tecres S.P.A. — Product Code HSD

K060535 is an FDA 510(k) premarket notification submitted by Tecres S.P.A. for the device "SPACER-S TEMPORARY SHOULDER SPACER". The FDA issued a decision of Substantially Equivalent on May 24, 2006. The device falls under product code HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented), a Class II device regulated under 21 CFR 888.3690. Tecres S.P.A. has at least 10 other 510(k) clearances on record.