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
176-200 of 376
Cleared Jan 19, 2011
R3 XLPE ANTEVERTED LINERS
K102370 · MBL
Orthopedic · 152d
Cleared Oct 05, 2010
JOURNEY UNICONDYLAR TIBIAL BASEPLATES
K102069 · HSX
Orthopedic · 74d
Cleared Sep 27, 2010
SMITH & NEPHEW CIRCULAR FIXATION SYSTEM
K093047 · KTT
Orthopedic · 362d
Cleared Sep 02, 2010
JET-X BAR SYSTEM CLAMPS AND POSTS REPROCESSING
K100795 · KTT
Orthopedic · 164d
Cleared Aug 26, 2010
JOURNEY CR KNEE SYSTEM
K101499 · JWH
Orthopedic · 86d
Cleared Jul 15, 2010
SMITH & NEPHEW MDF MODULAR SLEEVE
K100481 · MEH
Orthopedic · 147d
Cleared May 13, 2010
LEGION POROUS + HA TIBIAL BASEPLATES
K100897 · MBH
Orthopedic · 43d
Cleared May 05, 2010
BIOLOX DELTA CERAMIC FEMORAL HEADS
K100412 · LZO
Orthopedic · 78d
Cleared May 04, 2010
PERI-LOC LOCKING HOLE INSERTS AND CABLE ACCESSORIES
K100325 · HWC
Orthopedic · 89d
Cleared Apr 26, 2010
SURESHOT TAN NAILS AND ACCESSORIES
K092748 · HSB
Orthopedic · 230d
Cleared Apr 21, 2010
SMITH & NEPHEW HIP SYSTEMS WITH HA
K090982 · MEH
Orthopedic · 379d
Cleared Apr 15, 2010
SLR-PLUS STANDARD AND LATERAL FEMORAL STEMS
K093991 · LZO
Orthopedic · 112d
Cleared Apr 14, 2010
VERILAST WEAR CLAIMS FOR THE LEGION PRIMARY KNEE SYSTEM
K093746 · JWH
Orthopedic · 131d
Cleared Apr 05, 2010
SMITH & NEPHEW FOOTPRINT RCX PK SUTURE ANCHOR
K093935 · MBI
Orthopedic · 104d
Cleared Apr 01, 2010
SMITH & NEPHEW TWINFIX ULTRA HA SUTURE ANCHOR
K093844 · MAI
Orthopedic · 107d
Cleared Feb 23, 2010
SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V2.0
K100107 · OLO
Orthopedic · 40d
Cleared Feb 19, 2010
GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS
K100197 · HSX
Orthopedic · 28d
Cleared Jan 26, 2010
COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS
K093363 · MBL
Orthopedic · 90d
Cleared Jan 22, 2010
PATIENT SPECIFIC ACETABULAR RECONSTRUCTION PROSTHESIS
K092098 · LPH
Orthopedic · 192d
Cleared Dec 21, 2009
LEGION POROUS PLUS HA PRIMARY FEMORAL COMPONENTS
K091543 · MBH
Orthopedic · 209d
Cleared Dec 15, 2009
SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM
K093056 · NPJ
Orthopedic · 76d
Cleared Dec 15, 2009
SMITH & NEPHEW TWINFIX ULTRA PK SUTURE ANCHOR
K093228 · MBI
Orthopedic · 61d
Cleared Dec 10, 2009
AFGHAN EXTERNAL FIXATOR
K092002 · KTT
Orthopedic · 161d
Cleared Nov 03, 2009
R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS
K092386 · MBL
Orthopedic · 90d
Cleared Sep 29, 2009
JOURNEY BCS KNEE SYSTEM
K091014 · JWH
Orthopedic · 173d

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