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
530 devices
351-375 of 530
Cleared May 25, 2004
TRIGEN ADOLESCENT TAN
K040929 · HSB
Orthopedic · 46d
Cleared Apr 29, 2004
VERSABOND AB BONE CEMENT
K022688 · LOD
Orthopedic · 625d
Cleared Apr 14, 2004
SMITH AND NEPHEW TITANIUM INTERFERENCE SCREWS
K040331 · HWC
Orthopedic · 63d
Cleared Mar 23, 2004
TRIGEN TROCHANTERIC ANTEGRADE NAIL
K040462 · HSB
Orthopedic · 29d
Cleared Mar 16, 2004
SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
K034012 · GXI
Neurology · 83d
Cleared Feb 25, 2004
SMITH & NEPHEW ELECTROTHERMAL 20S SPINE GENERATOR, MODEL 7209975
K033981 · GEI
General & Plastic Surgery · 64d
Cleared Feb 20, 2004
TRIGEN INTERTAN
K040212 · JDS
Orthopedic · 21d
Cleared Jan 13, 2004
MODIFICATION TO JET-X HA COATED HALF PINS
K033289 · JDW
Orthopedic · 91d
Cleared Dec 10, 2003
SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS)
K033669 · HRS
Orthopedic · 19d
Cleared Dec 02, 2003
SMITH & NEPHEW IUR MORCELLATION SYSTEM
K031787 · HIH
Obstetrics & Gynecology · 175d
Cleared Nov 28, 2003
MODIFICATION TO VERSABOND BONE CEMENT
K033509 · LOD
Orthopedic · 22d
Cleared Nov 26, 2003
REFLECTION CONSTRAINED LINER
K033442 · KWZ
Orthopedic · 28d
Cleared Oct 29, 2003
TRIVEX SYSTEM
K032387 · DWQ
Cardiovascular · 86d
Cleared Oct 15, 2003
GENESIS II POROUS PLUS HA KNEE SYSTEM
K032683 · MBH
Orthopedic · 47d
Cleared Oct 01, 2003
TRIGEN STRAIGHT HUMERAL NAIL SYSTEM
K032722 · HSB
Orthopedic · 28d
Cleared Sep 26, 2003
SMITH & NEPHEW 300XL XENON LIGHT SOURCE-HERMES READY MODEL, 7210045
K032680 · GCJ
General & Plastic Surgery · 28d
Cleared Aug 21, 2003
GENESIS II POSTERIOR STABILIZED HIGH FLEXION ARTICULAR INSERT
K032295 · JWH
Orthopedic · 27d
Cleared Aug 08, 2003
TWIN FIX AB 6.5 MM SUTURE ANCHOR, MODELS 720209, 7210210, 7210211, 7210212
K032197 · MAI
Orthopedic · 21d
Cleared Aug 08, 2003
BIORCI SCREW
K032224 · HWC
Orthopedic · 18d
Cleared Jul 25, 2003
OXINIUM FEMORAL HEADS
K030766 · JDI
Orthopedic · 136d
Cleared Jul 14, 2003
EXTERNAL FIXATION SYSTEMS
K031181 · KTT
Orthopedic · 90d
Cleared Jul 01, 2003
TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318
K031685 · HWC
Orthopedic · 29d
Cleared Jun 20, 2003
SMITH & NEPHEW DYONICS ELECTROBLADE RESECTOR
K031675 · GEI
General & Plastic Surgery · 21d
Cleared Jun 18, 2003
INTELIJET FLUID MANAGEMENT SYSTEM HERMES-READY
K031605 · HRX
Orthopedic · 27d
Cleared May 27, 2003
GENESIS II TOTAL KNEE SYSTEM
K030612 · MBH
Orthopedic · 90d

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