510(k) K063445

PCA CONSTRAINED ACETABULAR LINERS by Howmedica Osteonics Corp. — Product Code KWZ

K063445 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp. for the device "PCA CONSTRAINED ACETABULAR LINERS". The FDA issued a decision of Substantially Equivalent on March 8, 2007. The device falls under product code KWZ (Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3310. Howmedica Osteonics Corp. has at least 10 other 510(k) clearances on record.