510(k) K220492

COPAL exchange G hip spacer by Heraeus Medical GmbH — Product Code KWY

K220492 is an FDA 510(k) premarket notification submitted by Heraeus Medical GmbH for the device "COPAL exchange G hip spacer". The FDA issued a decision of Substantially Equivalent on March 23, 2022. The device falls under product code KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented), a Class II device regulated under 21 CFR 888.3390. Heraeus Medical GmbH has at least 10 other 510(k) clearances on record.