510(k) K103010

STRYKER PATIENT SPECIFIC POLYMER IMPLANT by Howmedica Osteonics Corp., Dba Stryker Orthopaedics — Product Code KKY

K103010 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp., Dba Stryker Orthopaedics for the device "STRYKER PATIENT SPECIFIC POLYMER IMPLANT". The FDA issued a decision of Substantially Equivalent on October 26, 2010. The device falls under product code KKY (Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction), a Class II device regulated under 21 CFR 878.3500. Howmedica Osteonics Corp., Dba Stryker Orthopaedics has at least 10 other 510(k) clearances on record.