510(k) K191016

COPAL exchange G Hip and Knee Spacers by Heraeus Medical GmbH — Product Code KWY

K191016 is an FDA 510(k) premarket notification submitted by Heraeus Medical GmbH for the device "COPAL exchange G Hip and Knee Spacers". The FDA issued a decision of Substantially Equivalent on November 1, 2019. 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.