510(k) K192995

OsteoRemedies Hip Spacer System by Osteoremedies, LLC — Product Code KWL

K192995 is an FDA 510(k) premarket notification submitted by Osteoremedies, LLC for the device "OsteoRemedies Hip Spacer System". The FDA issued a decision of Substantially Equivalent on January 10, 2020. The device falls under product code KWL (Prosthesis, Hip, Hemi-, Femoral, Metal), a Class II device regulated under 21 CFR 888.3360. Osteoremedies, LLC has at least 10 other 510(k) clearances on record.