Medical Device Manufacturer · US , Memphis , TN

Smith & Nephew

17 submissions · 17 cleared · Since 2015
17
Total
17
Cleared
0
Denied

Smith & Nephew — FDA 510(k) Submissions

Smith & Nephew has submitted 17 FDA 510(k) premarket notifications since 2015, of which 17 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Endoscopic Central Control Unit, Plate, Fixation, Bone, Fastener, Fixation, Nondegradable, Soft Tissue, Device, Fixation, Proximal Femoral, Implant, Laparoscope, General & Plastic Surgery . Use the specialty filter in the sidebar to narrow results.

17 devices
1–17 of 17
EVOS Pelvic and Acetabular System
K241666 · HRS Plate, Fixation, Bone · Orthopedic
Feb 2025 254d
EVOS Patella Plates
K240487 · HRS Plate, Fixation, Bone · Orthopedic
Sep 2024 196d
Footprint Mini PK, 3.5mm Suture Anchor
K233730 · MBI Fastener, Fixation,... · Orthopedic
Jan 2024 57d
Q-FIX ULTRA All-Suture Anchor
K232457 · MBI Fastener, Fixation,... · Orthopedic
Sep 2023 25d
Smith & Nephew ACCORD? Cable System
K223762 · HRS Plate, Fixation, Bone · Orthopedic
May 2023 166d
Smith+Nephew INTELLIO Tablet
K221929 · ODA Endoscopic Central... · General & Plastic Surgery
Sep 2022 67d
Tablet Application
K203566 · ODA Endoscopic Central... · General & Plastic Surgery
May 2021 157d
Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation
K201253 · KTT Appliance, Fixation,... · Orthopedic
Dec 2020 211d
Smith+Nephew Arthroscopes
K201349 · HRX Arthroscope · Orthopedic
Jul 2020 60d
S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO, Autoclavable
K201198 · GCJ Laparoscope, General &... · General & Plastic Surgery
Jul 2020 74d
INTELLIO Tablet Application
K192876 · ODA Endoscopic Central... · General & Plastic Surgery
Feb 2020 142d
Smith & Nephew Tablet Application
K190367 · QGY Mobile / Tablet Software... · General & Plastic Surgery
May 2019 95d
CONQUEST FN
K172785 · JDO Device, Fixation,... · Orthopedic
Dec 2017 98d
NOVOS-NAIL Limb Lengthening System (LLS)
K163653 · HSB Rod, Fixation,... · Orthopedic
Oct 2017 294d
LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera Coupler, Tablet Application
K153606 · GCJ Laparoscope, General &... · General & Plastic Surgery
Jun 2016 168d
CONQUEST FN
K152686 · JDO Device, Fixation,... · Orthopedic
Mar 2016 181d
Smith and Nephew Legion Hinge Knee System
K151118 · KRO Prosthesis, Knee,... · Orthopedic
Jul 2015 92d
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