FDA 510(k) Applications Submitted by Marysa E. Loustalot

FDA 510(k) Number Submission Date Device Name Applicant
K200827 03/30/2020 LOCATOR R-Tx Ivory Super Holdco, Incp.
K160919 04/04/2016 Hansen Medical Magellan Robotic Catheter 9Fr HANSEN MEDICAL, INC.
K171894 06/26/2017 NuVasive« PreceptÖ Spinal System NuVasive, Incorporated
K173117 09/29/2017 NuVasive« VersaTieÖ System NuVasive, Inc.
K153304 11/16/2015 Hansen Medical Magellan Robotic Catheter eKit Hansen Medical, Inc.
K203701 12/18/2020 Locator Overdenture Implant System Ivory Super Holdco Inc. / Zest Anchors LLC
K170962 03/31/2017 NuVasive« CoRoent« Thoracolumbar System NuVasive, Incorporated
K191619 06/18/2019 TurboTemp EZ Zest Anchors, LLC
K172497 08/18/2017 NuVasive AttraX Scaffold NuVasive, Incorporated
K172676 09/05/2017 NuVasive« Modulus-C Interbody System NuVasive, Incorporated


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