510(k) K191433

AGILON® XO Shoulder Replacement System by Implantcast GmbH — Product Code HSD

K191433 is an FDA 510(k) premarket notification submitted by Implantcast GmbH for the device "AGILON® XO Shoulder Replacement System". The FDA issued a decision of Substantially Equivalent on November 12, 2020. The device falls under product code HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented), a Class II device regulated under 21 CFR 888.3690. Implantcast GmbH has at least 10 other 510(k) clearances on record.