510(k) K032126

PROMOS SHOULDER by Plus Orthopedics — Product Code HSD

K032126 is an FDA 510(k) premarket notification submitted by Plus Orthopedics for the device "PROMOS SHOULDER". The FDA issued a decision of Substantially Equivalent on January 8, 2004. 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 has at least 10 other 510(k) clearances on record.