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FDA 510(k) Applications Submitted by David Vancelette
FDA 510(k) Number
Submission Date
Device Name
Applicant
K140331
02/10/2014
ORTHALIGN PLUS SYSTEM
ORTHALIGN, INC
K181367
05/23/2018
Tenex Health TX System with the TXP MicroTip
Tenex Health, Inc.
K171780
06/15/2017
OrthAlign Plus System
OrthAlign, Inc.
K212556
08/13/2021
mi-eye 3 needlescope with cannula, mi-tablet 3
Trice Medical, Inc.
K172462
08/14/2017
OrthAlign Plus System
OrthAlign, Inc.
K162962
10/24/2016
OrthAlign Plus System
OrthAlign, Inc.
K153237
11/09/2015
OrthAlign Plus System
OrthAlign, Inc.
K163379
12/01/2016
KneeAlign 2 System
OrthAlign, Inc.
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