FDA 510(k) Applications Submitted by SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.

FDA 510(k) Number Submission Date Device Name Applicant
K991538 05/03/1999 OPERA CUPFLANGED ACETABULAR COMPONENTS SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.
K970713 02/27/1997 COMPASS UNIVERSAL HINGE SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.
K970635 02/20/1997 TITANIUM SPINAL ROD SYSTEM SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.
K971414 04/16/1997 ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADS SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.
K970751 03/03/1997 HEIDELBERG EXTERNAL FIXATOR SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.
K970748 03/03/1997 TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEM SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.
K970337 01/29/1997 HA GLOBAL TAPER (GT) TAPERED HIP STEM SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.
K970351 01/30/1997 GLOBAL TAPER SPECTRON HIP STEMS SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.
K962784 07/17/1996 ULTIUM SPINAL PLATING SYSTEM SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.
K963255 08/19/1996 PROFIX PLUS TIBIAL INSERT, PROFIX PS PLUS TIBIAL INSERT, PROFIX P/S TIBIAL INSERT SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact