Medical Device Manufacturer · US , Memphis , TN

Smith & Nephew, Inc., Orthopaedic Div. - FDA 510(k) Cleared Devices

10 submissions · 8 cleared · Since 1996

Recent clearances: OPERA CUPFLANGED ACETABULAR COMPONENTS, TITANIUM SPINAL ROD SYSTEM, ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADS

10

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Smith & Nephew, Inc., Orthopaedic Div. Orthopedic ✕

10 devices

1-10 of 10

Cleared Jun 03, 1999

OPERA CUPFLANGED ACETABULAR COMPONENTS

Orthopedic · 31d

Cleared Aug 14, 1997

TITANIUM SPINAL ROD SYSTEM

Orthopedic · 175d

Cleared Jul 16, 1997

ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADS

Orthopedic · 91d

Cleared May 09, 1997

TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEM

Orthopedic · 67d

Cleared Apr 16, 1997

HEIDELBERG EXTERNAL FIXATOR

Orthopedic · 44d

Cleared Apr 03, 1997

COMPASS UNIVERSAL HINGE

Orthopedic · 35d

Cleared Feb 28, 1997

HA GLOBAL TAPER (GT) TAPERED HIP STEM

Orthopedic · 30d

Cleared Feb 28, 1997

GLOBAL TAPER SPECTRON HIP STEMS

Orthopedic · 29d

Cleared Jan 02, 1997

PROFIX PLUS TIBIAL INSERT, PROFIX PS PLUS TIBIAL INSERT, PROFIX P/S TIBIAL...

Orthopedic · 136d

Cleared Oct 02, 1996

ULTIUM SPINAL PLATING SYSTEM

Orthopedic · 77d