510(k) K101356

Spacer-G and Spacer-K by Tecres S.P.A. — Product Code KWL

K101356 is an FDA 510(k) premarket notification submitted by Tecres S.P.A. for the device "Spacer-G and Spacer-K". The FDA issued a decision of Substantially Equivalent on September 20, 2011. The device falls under product code KWL (Prosthesis, Hip, Hemi-, Femoral, Metal), a Class II device regulated under 21 CFR 888.3360. Tecres S.P.A. has at least 10 other 510(k) clearances on record.