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
151-175 of 530
Cleared Jan 23, 2013
FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL
K123579 · MBI
Orthopedic · 65d
Cleared Nov 20, 2012
ARTHROSCOPIC SURGICAL INSTRUMENTS - INTERFERENCE SCREW SYSTEMS
K122596 · HWC
Orthopedic · 88d
Cleared Oct 24, 2012
SMITH & NEPHEW SMF HIP STEM
K123012 · LPH
Orthopedic · 26d
Cleared Oct 19, 2012
SMITH & NEPHEW, INC. INTRAMEDULLARY NAIL SYSTEM INSTRUMENTATION
K122170 · HSB
Orthopedic · 88d
Cleared Oct 18, 2012
SMITH & NEPHEW ULTRA FAST-FIX MENISCAL REPAIR SYSTEM, SMITH & NEPHEW ULTRA...
K121861 · GAT
General & Plastic Surgery · 114d
Cleared Oct 16, 2012
SMITH & NEPHEW R3 CONSTRAINED LINERS
K122139 · KWZ
Orthopedic · 89d
Cleared Oct 15, 2012
SMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEM
K121627 · MEH
Orthopedic · 133d
Cleared Oct 05, 2012
SMITH & NEPHEW RADIOPAQUE TRIAL NECKS
K113039 · MEH
Orthopedic · 359d
Cleared Sep 07, 2012
SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS
K121714 · HSD
Orthopedic · 88d
Cleared Aug 28, 2012
SL-PLUS MIA FEMORAL STEMS WITH TI/HA COATING
K122296 · LZO
Orthopedic · 28d
Cleared Aug 23, 2012
POLARCUP DUAL MOBILITY SYSTEM
K122244 · LPH
Orthopedic · 27d
Cleared Aug 13, 2012
JOURNEY II CR KNEE SYSTEM
K121443 · JWH
Orthopedic · 90d
Cleared Aug 07, 2012
SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION
K121393 · MBH
Orthopedic · 90d
Cleared Jul 19, 2012
SL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATING
K120211 · LZO
Orthopedic · 177d
Cleared Jun 22, 2012
BIORAPTOR 2.9, BIORAPTOR 2.3 PK, OSTEORAPTOR, & BIORAPTOR KNOTLESS SUTURE AN
K121018 · MBI
Orthopedic · 79d
Cleared Jun 07, 2012
SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION
K120871 · JDW
Orthopedic · 77d
Cleared May 18, 2012
GENESIS II PS NON-MODULAR FEMORAL COMPONENT
K120698 · JWH
Orthopedic · 72d
Cleared May 16, 2012
PICO SINGLE USE NEGATIVE PRESSURE WOUND THERAPY SYSTEM
K112127 · OMP
General & Plastic Surgery · 296d
Cleared Apr 27, 2012
R3 XLPE LINERS
K113848 · MBL
Orthopedic · 120d
Cleared Apr 19, 2012
MODULAR PROXIMALLY FLUTED HIP STEM
K113789 · MEH
Orthopedic · 119d
Cleared Apr 04, 2012
VLP 2.7MM EXTRA LARGE PERCUTANEOUS CALCANEUS PLATE, PERI-LOC 3.5MM ANTERIOR...
K120667 · HRS
Orthopedic · 30d
Cleared Mar 06, 2012
FOOTPRINT ULTRA PK SUTURE ANCHOR
K113274 · MBI
Orthopedic · 120d
Cleared Feb 27, 2012
JOURNEY II DEEP DISHED ARTICULAR INSERTS
K113482 · JWH
Orthopedic · 96d
Cleared Jan 31, 2012
TWINFIX ULTRA TI, TWINFIX ULTRA PK, TWINFIX ULTRA HA SUTURE ANCHORS
K112526 · MBI
Orthopedic · 153d
Cleared Jan 20, 2012
SMITH & NEPHEW HEALICOIL PK SUTURE ANCHOR
K113294 · MBI
Orthopedic · 73d

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