FDA 510(k) Applications Submitted by Ivette Galmez
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K210050 |
01/08/2021 |
Augmented VaultLock Glenoid |
Arthrex Inc. |
| K170206 |
01/24/2017 |
Arthrex FiberTape Cerclage |
ARTHREX, INC. |
| K160319 |
02/05/2016 |
FiberTak DR |
ARTHREX, INC. |
| K190288 |
02/11/2019 |
Arthrex Tenodesis Button |
Arthrex Inc. |
| K200433 |
02/21/2020 |
iBalance UKA Tibial Tray Implant |
Arthrex Inc. |
| K170547 |
02/24/2017 |
Arthrex Mesh Plate System |
Arthrex, Inc. |
| K130510 |
02/27/2013 |
ARTHREX COMPRESSION PLATES |
ARTHREX, INC. |
| K180594 |
03/06/2018 |
Knotless SutureTak Anchors |
Arthrex, Inc. |
| K220947 |
04/01/2022 |
Arthrex Knotless AC Repair Devices |
Arthrex Inc. |
| K200895 |
04/03/2020 |
Univers Revers Modular Glenoid System, Half Augment Baseplate |
Arthrex Inc. |
| K211074 |
04/12/2021 |
Univers Revers Modular Glenoid System, Standard Augment Baseplates |
Arthrex Inc. |
| K221232 |
04/29/2022 |
Univers Revers Humeral Cup Implant |
Arthrex Inc. |
| K171296 |
05/02/2017 |
SutureTape |
Arthrex, Inc. |
| K151230 |
05/08/2015 |
Arthrex FiberTak Anchors |
Arthrex, Inc. |
| K191426 |
05/29/2019 |
FiberTak Button |
Arthrex Inc. |
| K181513 |
06/08/2018 |
Arthrex PushLock Tenodesis Anchor |
Arthrex Inc. |
| K091844 |
06/22/2009 |
ARTHREX BIO-COMPOSITE SUTURETAK ANCHORS |
ARTHREX, INC. |
| K222007 |
07/07/2022 |
Arthrex Virtual Implant Positioning (VIP) System |
Arthrex Inc. |
| K191960 |
07/23/2019 |
Arthrex Univers Revers Modular Glenoid System |
Arthrex Inc. |
| K122374 |
08/06/2012 |
ARTHREX SUTURE (UHMWPE) |
ARTHREX, INC. |
| K172612 |
08/31/2017 |
FiberTak DX |
Arthex, Inc |
| K192532 |
09/16/2019 |
Arthrex SwiveLock Anchor |
Arthrex Inc. |
| K233260 |
09/29/2023 |
Univers Revers CA Head and Adapter |
Arthrex Inc. |
| K193372 |
12/05/2019 |
Univers Revers Modular Glenoid System (Augemented baseplates) |
Arthrex Inc. |
| K193575 |
12/23/2019 |
Arthrex SutureTape |
Arthrex Inc. |
| K243995 |
12/26/2024 |
Arthrex Humeral Plating System and Cerclage Button |
Arthrex Inc. |
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