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
51-75 of 530
Cleared Apr 02, 2021
Extended HA Half Pins
K210784 · JDW
Orthopedic · 17d
Cleared Mar 25, 2021
LEGION Porous CR Narrow Femoral Components
K210566 · MBH
Orthopedic · 27d
Cleared Feb 01, 2021
FAST-FIX FLEX
K203393 · GAT
General & Plastic Surgery · 75d
Cleared Jan 27, 2021
EVOS Large Fragment Plating System
K203405 · HRS
Orthopedic · 69d
Cleared Nov 16, 2020
EVOS Large Fragment Plating System
K201918 · HRS
Orthopedic · 129d
Cleared Nov 16, 2020
Circular Fixation with Balanced Cable Transport
K202762 · KTT
Orthopedic · 56d
Cleared Oct 06, 2020
R3 HA Coated Acetabular Shells
K201701 · MBL
Orthopedic · 106d
Cleared Jul 22, 2020
EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)
K201527 · HRS
Orthopedic · 44d
Cleared Jun 04, 2020
Journey II XR Knee Instrument
K200227 · JWH
Orthopedic · 126d
Cleared Apr 24, 2020
Smith&Nephew VISIONAIRE Patient Matched Cutting Blocks
K200826 · JWH
Orthopedic · 25d
Cleared Mar 18, 2020
HEALICOIL Knotless Suture Anchors
K193558 · MAI
Orthopedic · 86d
Cleared Mar 13, 2020
LEGION Inserts with JRNY Lock
K200407 · JWH
Orthopedic · 23d
Cleared Feb 28, 2020
CONQUEST FN
K193029 · JDO
Orthopedic · 121d
Cleared Oct 31, 2019
OR3O Dual Mobility System
K191002 · LPH
Orthopedic · 198d
Cleared Oct 25, 2019
REDAPT Blade Augments
K190847 · LPH
Orthopedic · 207d
Cleared Sep 04, 2019
Smith & Nephew DYONICS 25 Fluid Management System
K192155 · HRX
General & Plastic Surgery · 26d
Cleared Jul 25, 2019
JOURNEY II Unicompartmental Knee System
K191211 · HSX
Orthopedic · 80d
Cleared Mar 11, 2019
EVOS Small Fragment Upper Extremity Plates Line Additions
K190253 · HRS
Orthopedic · 32d
Cleared Feb 11, 2019
Journey II Unicompartmental Knee System
K190085 · HSX
Orthopedic · 25d
Cleared Nov 28, 2018
Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks
K183010 · JWH
Orthopedic · 28d
Cleared Nov 19, 2018
R3 Anteverted Liners
K182535 · MBL
Orthopedic · 66d
Cleared Nov 16, 2018
REDAPT Modular Acetabular Shell
K182109 · LPH
Orthopedic · 105d
Cleared Sep 24, 2018
REDAPT Porous Acetabular Shell
K181366 · LPH
Orthopedic · 124d
Cleared Aug 09, 2018
EVOS Wrist Fracture Plating System
K181533 · HRS
Orthopedic · 59d
Cleared Apr 24, 2018
Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter
K180277 · OLO
Orthopedic · 83d

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