Smith & Nephew, Inc. - FDA 510(k) Cleared Devices
530
Total
517
Cleared
0
Denied
376 devices
Cleared
Apr 02, 2021
Extended HA Half Pins
Orthopedic
17d
Cleared
Mar 25, 2021
LEGION Porous CR Narrow Femoral Components
Orthopedic
27d
Cleared
Jan 27, 2021
EVOS Large Fragment Plating System
Orthopedic
69d
Cleared
Nov 16, 2020
EVOS Large Fragment Plating System
Orthopedic
129d
Cleared
Nov 16, 2020
Circular Fixation with Balanced Cable Transport
Orthopedic
56d
Cleared
Oct 06, 2020
R3 HA Coated Acetabular Shells
Orthopedic
106d
Cleared
Jul 22, 2020
EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)
Orthopedic
44d
Cleared
Jun 04, 2020
Journey II XR Knee Instrument
Orthopedic
126d
Cleared
Apr 24, 2020
Smith&Nephew VISIONAIRE Patient Matched Cutting Blocks
Orthopedic
25d
Cleared
Mar 18, 2020
HEALICOIL Knotless Suture Anchors
Orthopedic
86d
Cleared
Mar 13, 2020
LEGION Inserts with JRNY Lock
Orthopedic
23d
Cleared
Feb 28, 2020
CONQUEST FN
Orthopedic
121d
Cleared
Oct 31, 2019
OR3O Dual Mobility System
Orthopedic
198d
Cleared
Oct 25, 2019
REDAPT Blade Augments
Orthopedic
207d
Cleared
Jul 25, 2019
JOURNEY II Unicompartmental Knee System
Orthopedic
80d
Cleared
Mar 11, 2019
EVOS Small Fragment Upper Extremity Plates Line Additions
Orthopedic
32d
Cleared
Feb 11, 2019
Journey II Unicompartmental Knee System
Orthopedic
25d
Cleared
Nov 28, 2018
Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks
Orthopedic
28d
Cleared
Nov 19, 2018
R3 Anteverted Liners
Orthopedic
66d
Cleared
Nov 16, 2018
REDAPT Modular Acetabular Shell
Orthopedic
105d
Cleared
Sep 24, 2018
REDAPT Porous Acetabular Shell
Orthopedic
124d
Cleared
Aug 09, 2018
EVOS Wrist Fracture Plating System
Orthopedic
59d
Cleared
Apr 24, 2018
Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter
Orthopedic
83d
Cleared
Mar 05, 2018
LEGION Knee System
Orthopedic
27d
Cleared
Jan 10, 2018
Smith & Nephew Patient Matched Cutting Blocks
Orthopedic
161d
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