FDA 510(k) Applications Submitted by GINO ROUSS

FDA 510(k) Number Submission Date Device Name Applicant
K120871 03/22/2012 SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION SMITH & NEPHEW, INC.
K061011 04/12/2006 COMPETITOR UNICONDYLAR KNEE TIBIAL BASEPLATE SMITH & NEPHEW, INC.
K051086 04/28/2005 SMITH & NEPHEW PATELLO-FEMORAL IMPLANT SMITH & NEPHEW, INC.
K061243 05/03/2006 SMITH & NEPHEW MODULAR FEMORAL HEAD SMITH & NEPHEW, INC.
K121393 05/09/2012 SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION SMITH & NEPHEW, INC.
K061779 06/26/2006 COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE SMITH & NEPHEW, INC.
K102069 07/23/2010 JOURNEY UNICONDYLAR TIBIAL BASEPLATES SMITH & NEPHEW, INC.
K022460 07/26/2002 SMITH & NEPHEW IMAGE GUIDED SURGICAL SYSTEM FOR KNEE APPLICATIONS SMITH & NEPHEW, INC.
K062408 08/17/2006 SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD SMITH & NEPHEW, INC.
K052275 08/22/2005 SMITH & NEPHEW PLATFORM HIP STEM SMITH & NEPHEW, INC.
K113038 10/12/2011 SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM INSTRUMENTS SMITH & NEPHEW, INC.
K083565 12/03/2008 PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0 SMITH & NEPHEW, INC.
K043440 12/14/2004 SMITH & NEPHEW, INC. REVISION KNEE SYSTEM SMITH & NEPHEW, INC.
K030623 02/27/2003 SMITH & NEPHEW PROFIX TOTAL KNEE SYSTEM SMITH & NEPHEW, INC.
K021798 05/31/2002 SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS SMITH & NEPHEW, INC.
K021815 06/03/2002 SMITH & NEPHEW IMAGE SURGICAL INSTRUMENTS FOR TRAUMA APPLICATIONS SMITH & NEPHEW, INC.
K052265 08/19/2005 SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL SMITH & NEPHEW, INC.


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