Medical Device Manufacturer · US , Mchenry , IL

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

530 submissions · 517 cleared · Since 1980
530
Total
517
Cleared
0
Denied
376 devices
326-350 of 376
Cleared Jul 11, 2002
AMC ANTIMICROBIAL PIN/WIRE SLEEVE
K012193 · JEC
Orthopedic · 364d
Cleared Jun 11, 2002
TOTAL HIP FEMORAL HEAD - 12/14 TAPER
K021673 · LZO
Orthopedic · 21d
Cleared Mar 26, 2002
SMITH & NEPHEW TWINFIX TI QUICK T
K020159 · HWC
Orthopedic · 68d
Cleared Mar 15, 2002
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE...
K012778 · JWH
Orthopedic · 207d
Cleared Mar 15, 2002
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE...
K012787 · LPH
Orthopedic · 207d
Cleared Mar 15, 2002
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UNMWPE COMPONENTS IN THE...
K012788 · KWS
Orthopedic · 207d
Cleared Dec 19, 2001
ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPER
K013989 · LZO
Orthopedic · 15d
Cleared Dec 13, 2001
3D HUMERAL HEADS
K012378 · KWS
Orthopedic · 140d
Cleared Dec 05, 2001
MODIFICATION TO REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS
K013658 · LPH
Orthopedic · 29d
Cleared Nov 02, 2001
SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT
K011985 · MAI
Orthopedic · 129d
Cleared Jun 27, 2001
SMITH AND NEPHEW 5.00MM ABSORBABLE POLYMER ANCHOR
K011299 · MAI
Orthopedic · 58d
Cleared May 25, 2001
JAX GRANULES BONE VOID FILLER
K010557 · MQV
Orthopedic · 88d
Cleared Mar 07, 2001
SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW
K002274 · HWC
Orthopedic · 224d
Cleared Feb 15, 2001
DYONICS CONTROL RF SYSTEM
K003572 · HRX
Orthopedic · 87d
Cleared Feb 15, 2001
SMITH & NEPHEW SUTURE ANCHOR
K003599 · HWC
Orthopedic · 86d
Cleared Feb 14, 2001
COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS
K003566 · KWS
Orthopedic · 86d
Cleared Dec 15, 2000
REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS
K002747 · LPH
Orthopedic · 101d
Cleared Dec 11, 2000
VERSABOND BONE CEMENT
K001160 · LOD
Orthopedic · 245d
Cleared Dec 11, 2000
SYNERGY HA COATED POROUS FEMORAL STEMS
K002996 · MEH
Orthopedic · 77d
Cleared Nov 30, 2000
TIBIAL & PATELLAR COMPONENTS FOR THE PROFIX & GENESIS II TOTAL KNEE SYSTEMS
K002740 · JWH
Orthopedic · 90d
Cleared Jun 26, 2000
SMITH + NEPHEW RF ARTHROSCOPIC WAND SYSTEM
K001226 · HRX
Orthopedic · 70d
Cleared Jun 14, 2000
MICROPERFORATION INSTRUMENT
K001507 · LXH
Orthopedic · 30d
Cleared May 23, 2000
NEER III TOTAL SHOULDER SYSTEM
K994350 · KWS
Orthopedic · 152d
Cleared Feb 25, 2000
RADIAL HEAD PROSTHESIS
K992220 · KWI
Orthopedic · 239d
Cleared Feb 25, 2000
ACUFEX SPIKED WASHER SYSTEM, ACUFEX SUTURE WASHER SYSTEM, ACUFEX CANCELLOUS...
K994202 · HWC
Orthopedic · 74d

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