Medical Device Manufacturer · US , Andover , MA

Smith and Nephew, Inc. - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2016

Recent clearances: Regeneten Bioinductive Implant, SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENABLED (72205447), SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NON-NETWORK ENABLED (72205448), LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head

7

Total

7

Cleared

0

Denied

FDA 510(k) Regulatory Record - Smith and Nephew, Inc. Orthopedic ✕

5 devices

1-5 of 5

Cleared May 11, 2023

Regeneten Bioinductive Implant

Orthopedic · 266d

Cleared Mar 12, 2019

Double ENDOBUTTON Fixation Device

Orthopedic · 112d

Cleared Sep 28, 2018

MICRORAPTOR Knotless Suture Anchor

Orthopedic · 88d

Cleared May 30, 2018

MICRORAPTOR REGENESORB Suture Anchor

Orthopedic · 110d

Cleared Dec 07, 2016

SUTUREFIX Curved Suture Anchor

Orthopedic · 37d