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
26-50 of 530
Cleared May 04, 2023
Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System,...
K230653 · JWH
Orthopedic · 56d
Cleared Mar 30, 2023
Cemented Tibia Baseplate no Taper with JRNY Lock
K230555 · JWH
Orthopedic · 30d
Cleared Feb 17, 2023
ULTRABUTTON QUAD Adjustable Fixation Device
K222971 · MBI
Orthopedic · 143d
Cleared Jan 03, 2023
AETOS Shoulder System
K220847 · KWS
Orthopedic · 286d
Cleared Dec 08, 2022
MAVERICK Mini External Fixation System
K223112 · JDW
Orthopedic · 66d
Cleared Nov 14, 2022
Smith & Nephew Intramedullary Nail Systems
K210980 · HSB
Orthopedic · 592d
Cleared Oct 28, 2022
JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System
K222653 · NJD
Orthopedic · 57d
Cleared Oct 18, 2022
EVOS Wrist Spanning Plate
K213123 · HRS
Orthopedic · 386d
Cleared Sep 29, 2022
Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad,...
K213126 · JDO
Orthopedic · 367d
Cleared Aug 25, 2022
Acute QC Strut and Components
K221792 · OSN
Orthopedic · 65d
Cleared Aug 18, 2022
OR3O Dual Mobility System
K220959 · LPH
Orthopedic · 139d
Cleared Jul 26, 2022
Cemented Round Patella with JRNY Pegs
K221939 · JWH
Orthopedic · 25d
Cleared Jul 01, 2022
Smith & Nephew Hip Systems
K211176 · LPH
Orthopedic · 437d
Cleared Apr 26, 2022
Legion Inserts with JRNY Lock
K220896 · JWH
Orthopedic · 29d
Cleared Mar 11, 2022
TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN...
K213827 · KWS
Orthopedic · 93d
Cleared Feb 11, 2022
MAVERICK External Fixation System
K213874 · JDW
Orthopedic · 60d
Cleared Jan 19, 2022
R3 Large Head Liners
K211330 · LPH
Orthopedic · 261d
Cleared Oct 01, 2021
Porous Patella and Porous Tibia Baseplate
K211221 · MBH
Orthopedic · 161d
Cleared Sep 16, 2021
VISIONAIRE UK Patient Matched Cutting Guides
K211512 · HSX
Orthopedic · 125d
Cleared Aug 17, 2021
Journey II Mid-Level Tibial Inserts
K211671 · JWH
Orthopedic · 77d
Cleared Jul 29, 2021
SMART Taylor Spatial Frame
K210953 · KTT
Orthopedic · 121d
Cleared Jul 22, 2021
POLARSTEM Cemented Femoral Stem
K203175 · LZO
Orthopedic · 269d
Cleared Jul 19, 2021
POLARSTEM Calcar Reamer Guide
K211548 · LZO
Orthopedic · 61d
Cleared Jun 29, 2021
Smith & Nephew Plates and Screws
K210837 · HRS
Orthopedic · 99d
Cleared May 24, 2021
LEGION CR Porous Plus HA Femoral Components
K211246 · MBH
Orthopedic · 28d

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