510(k) K234028

COPAL® exchange G hip spacer; COPAL® G+V by Heraeus Medical GmbH — Product Code KWL

K234028 is an FDA 510(k) premarket notification submitted by Heraeus Medical GmbH for the device "COPAL® exchange G hip spacer; COPAL® G+V". The FDA issued a decision of Substantially Equivalent on February 15, 2024. The device falls under product code KWL (Prosthesis, Hip, Hemi-, Femoral, Metal), a Class II device regulated under 21 CFR 888.3360. Heraeus Medical GmbH has at least 10 other 510(k) clearances on record.