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
226-250 of 376
Cleared Mar 04, 2008
TWINFIX PK FP SUTURE ANCHOR
K073509 · HWC
Orthopedic · 82d
Cleared Jan 10, 2008
SMITH & NEPHEW MIS HIP STEM
K072417 · LPH
Orthopedic · 135d
Cleared Dec 20, 2007
JOURNEY UNICONDYLAR FEMORAL IMPLANT
K073175 · HSX
Orthopedic · 37d
Cleared Dec 20, 2007
LEGION POROUS PRIMARY
K073325 · MBH
Orthopedic · 23d
Cleared Dec 06, 2007
LEGION STEM WITH HOLES
K072531 · JWH
Orthopedic · 90d
Cleared Nov 20, 2007
TC-PLUS PRIMARY KNEE SYSTEM
K072858 · JWH
Orthopedic · 46d
Cleared Nov 19, 2007
PERI-LOC PERIARTRICULAR LCK PIT SYS-PROX FEM PLATES/SCREWS.CALBE ACCESS
K072818 · HRS
Orthopedic · 48d
Cleared Nov 09, 2007
POLYGRAFT BGS
K062607 · MQV
Orthopedic · 430d
Cleared Oct 15, 2007
SMITH & NEPHEW ARTHROSCOPE
K072675 · HRX
Orthopedic · 24d
Cleared Sep 19, 2007
CROSSLINKED POLYETHYLENE ARTICULAR INSERTS
K071071 · JWH
Orthopedic · 156d
Cleared Aug 17, 2007
GENESIS II TOTAL KNEE SYSTEM, LEGION REVISION KNEE SYSTEM, JOURNEY BCS KNEE...
K071790 · MBH
Orthopedic · 46d
Cleared Aug 08, 2007
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM
K071563 · HRS
Orthopedic · 62d
Cleared Jun 06, 2007
SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM
K070756 · MBL
Orthopedic · 78d
Cleared May 18, 2007
COFIELD TOTAL SHOULDER SYSTEM
K070565 · MBF
Orthopedic · 79d
Cleared Jan 19, 2007
SMITH & NEPHEW DUONICS POWER II SHAVER SYSTEM
K062849 · HRX
Orthopedic · 116d
Cleared Sep 15, 2006
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM
K062216 · HRS
Orthopedic · 45d
Cleared Sep 12, 2006
SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD
K062408 · KWL
Orthopedic · 26d
Cleared Aug 10, 2006
KNEE FUSION NAIL
K061783 · JDS
Orthopedic · 45d
Cleared Aug 04, 2006
COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE
K061779 · HSX
Orthopedic · 39d
Cleared Jul 17, 2006
SMITH & NEPHEW MODULAR FEMORAL HEAD
K061243 · KWL
Orthopedic · 75d
Cleared Jul 12, 2006
PATIENT MATCHED HIP STEM
K053246 · LZO
Orthopedic · 233d
Cleared Jul 11, 2006
COMPETITOR UNICONDYLAR KNEE TIBIAL BASEPLATE
K061011 · HSX
Orthopedic · 90d
Cleared Jul 06, 2006
SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTS
K061569 · NPJ
Orthopedic · 30d
Cleared Jun 14, 2006
REFLECTION 3-HOLE SHELL WITH ASYMMETRIC POROUS COATING
K060630 · LPH
Orthopedic · 97d
Cleared Jun 08, 2006
KINSA SUTURE ANCHOR
K061154 · MBI
Orthopedic · 43d

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