510(k) K062274

SPACER-K TEMPORARY KNEE SPACER WITH GENTAMICIN, MODELS SPK0021, SPK0121, SPK0221, SPK0321 by Tecres S.P.A. — Product Code JWH

K062274 is an FDA 510(k) premarket notification submitted by Tecres S.P.A. for the device "SPACER-K TEMPORARY KNEE SPACER WITH GENTAMICIN, MODELS SPK0021, SPK0121, SPK0221, SPK0321". The FDA issued a decision of Substantially Equivalent on May 22, 2008. The device falls under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. Tecres S.P.A. has at least 10 other 510(k) clearances on record.