510(k) K062273

SPACER-G TEMPORARY HIP PROSTHESIS by Tecres S.P.A. — Product Code KWL

K062273 is an FDA 510(k) premarket notification submitted by Tecres S.P.A. for the device "SPACER-G TEMPORARY HIP PROSTHESIS". The FDA issued a decision of Substantially Equivalent on May 22, 2008. 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.