510(k) K063578

PROMOS MODULAR SHOULDER SYSTEM by Plus Orthopedics AG — Product Code HSD

K063578 is an FDA 510(k) premarket notification submitted by Plus Orthopedics AG for the device "PROMOS MODULAR SHOULDER SYSTEM". The FDA issued a decision of Substantially Equivalent on March 2, 2007. The device falls under product code HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented), a Class II device regulated under 21 CFR 888.3690. Plus Orthopedics AG has at least 10 other 510(k) clearances on record.