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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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