FDA 510(k) Applications Submitted by David L Roger

FDA 510(k) Number Submission Date Device Name Applicant
K143139 11/03/2014 Arthrex Fracture System ARTHREX, INC.
K143702 12/24/2014 Arthrex Blunt Tip Screws with Fiber Tape Arthrex, Inc.
K150456 02/20/2015 Arthrex Plates, Screws, and Staples Arthrex, Inc.
K190707 03/19/2019 Arthrex SoftStitch Arthrex Inc.
K140855 04/03/2014 ARTHREX SUTURETAK SUTURE ANCHORS ARTHREX, INC.
K171020 04/05/2017 Arthrex Knotless SutureTak Anchor Arthrex Inc.
K161060 04/15/2016 Arthrex iBalance UKA System Vitamin E Tibial Bearing Arthrex, Inc.
K151078 04/22/2015 Arthrex RetroFusion Screw ARTHREX, INC.
K151092 04/23/2015 Arthrex Short Suture Anchors Arthrex, Inc.
K141478 06/04/2014 ARTHREX FRACTURE PLATES AND SCREWS ARTHREX, INC.
K201542 06/09/2020 Arthrex Eclipse Shoulder Prosthesis System Arthrex, Inc.
K141577 06/13/2014 ARTHREX PIP DART ARTHREX, INC.
K161782 06/29/2016 Arthrex Univers Revers Shoulder Prosthesis System ARTHREX, INC.
K182799 10/02/2018 Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads Arthrex Inc.
K203100 10/14/2020 Arthrex Eclipse Titanium Humeral Head Arthrex Inc.
K153218 11/05/2015 Arthrex Synergy UHD4 System ARTHREX, INC.
K183194 11/19/2018 Arthrex Eclipse Shoulder Prosthesis System Arthrex Inc.
K173788 12/14/2017 Arthrex Corkscrew FT Arthrex Inc.
K143614 12/19/2014 Arthrex Low Profile Screws ARTHREX, INC.
K173845 12/19/2017 Arthrex SwiveLock Arthrex Inc.
K143745 12/31/2014 Arthrex Corkscrew and SwiveLock Suture Anchors Arthrex, Inc.
K170382 02/07/2017 Arthrex Compression Screws Arthrex Inc.
K170414 02/10/2017 Arthrex Univers Revers Apex Humeral Stems Arthrex Inc.
K171141 04/18/2017 Arthrex SwiveLock Anchors Arthrex Inc.
K191226 05/07/2019 Arthrex SwiveLock Suture Anchor Arthrex Inc.
K171365 05/09/2017 Arthrex Knee Systems Arthrex Inc.
K151342 05/19/2015 Arthrex SwiveLock Anchors ARTHREX, INC.
K181555 06/13/2018 Arthrex Fracture Adapter Hemi Shoulder Prosthesis Arthrex Inc.
K171841 06/20/2017 Arthrex Shoulder System Arthrex Inc.
K181769 07/03/2018 Arthrex FiberTak Suture Anchor Arthrex, Inc.
K212415 08/03/2021 Arthrex Modular Glenoid System-Titanium Glenosphere Arthrex Inc.
K173240 10/05/2017 Arthrex PushLock Arthrex Inc.


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