FDA 510(k) Applications Submitted by Smith and Nephew, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K163034 10/31/2016 SUTUREFIX Curved Suture Anchor Smith and Nephew, Inc.
K183232 11/20/2018 Double ENDOBUTTON Fixation Device Smith and Nephew, Inc.
K181746 07/02/2018 MICRORAPTOR Knotless Suture Anchor Smith and Nephew, Inc.
K191177 05/02/2019 LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head Smith and Nephew, Inc.
K221740 06/15/2022 SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENABLED (72205447), SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NON-NETWORK ENABLED (72205448) Smith and Nephew, Inc.


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