510(k) K172906

REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement by Osteoremedies, LLC — Product Code KWL

K172906 is an FDA 510(k) premarket notification submitted by Osteoremedies, LLC for the device "REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement". The FDA issued a decision of Substantially Equivalent on August 29, 2018. 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.