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
101-125 of 376
Cleared Nov 16, 2015
REDAPT Porous Acetabular Shell and Cemented Liner
K150790 · LPH
Orthopedic · 236d
Cleared Nov 12, 2015
VLP Mini-Mod Talus Plates
K152976 · HRS
Orthopedic · 35d
Cleared Oct 28, 2015
JOURNEY II Uni Tibial Base and Insert
K152315 · HSX
Orthopedic · 72d
Cleared Oct 27, 2015
Genesis II XLPE Resurfacing Patellar Components
K150241 · JWH
Orthopedic · 267d
Cleared Oct 21, 2015
JOURNEY II XR Knee System
K152726 · JWH
Orthopedic · 29d
Cleared Sep 03, 2015
REDAPT¿ Revision Femoral System
K151902 · LZO
Orthopedic · 55d
Cleared Jul 28, 2015
Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and...
K151105 · MAI
Orthopedic · 95d
Cleared Apr 20, 2015
POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA
K143739 · LZO
Orthopedic · 111d
Cleared Mar 24, 2015
SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HA
K143096 · LZO
Orthopedic · 147d
Cleared Feb 12, 2015
Visionaire Disposable Instruments
K143226 · JWH
Orthopedic · 94d
Cleared Feb 04, 2015
ACL SMART System
K143172 · MAI
Orthopedic · 92d
Cleared Jan 13, 2015
BIOSURE REGENESORB interference Screw
K142948 · MAI
Orthopedic · 95d
Cleared Dec 22, 2014
ANTHEM PS Total Knee System
K142807 · JWH
Orthopedic · 84d
Cleared Dec 18, 2014
VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws
K143050 · HRS
Orthopedic · 56d
Cleared Nov 20, 2014
Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software
K142520 · KTT
Orthopedic · 73d
Cleared Nov 14, 2014
JOURNEY II XR KNEE SYSTEM
K141471 · JWH
Orthopedic · 164d
Cleared Aug 21, 2014
SMITH & NEPHEW DISPOSABLE FIN PUNCH
K141585 · JWH
Orthopedic · 69d
Cleared Jul 21, 2014
BIOSURE HEALICOIL PK INTERFERENCE SCREW
K140879 · MBI
Orthopedic · 105d
Cleared May 29, 2014
JOURNEY II BCS CONSTRAINED INSERTS
K140555 · JWH
Orthopedic · 86d
Cleared May 15, 2014
SMITH & NEPHEW CANNULATED CAPTURED SCREW
K133662 · HWC
Orthopedic · 167d
Cleared May 07, 2014
EVOS MINI-FRAGMENT PLATING SYSTEM
K140814 · HRS
Orthopedic · 36d
Cleared Feb 04, 2014
SMITH & NEPHEW VARIABLE-ANGLE LOCKING MINI-FRAGMENT PLATING SYSTEM
K132886 · HRS
Orthopedic · 141d
Cleared Jan 07, 2014
D-RAD SMART PACK
K132296 · HRS
Orthopedic · 168d
Cleared Dec 11, 2013
SMITH & NEPHEW PATIENT MATCHED CUTTING BLOCKS
K130708 · JWH
Orthopedic · 271d
Cleared Oct 22, 2013
SMITH & NEPHEW GLOBAL FEMORAL HEAD TRIALS
K132435 · LZO
Orthopedic · 78d

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