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. |
| K241700 |
06/13/2024 |
Tenex 2nd Generation System |
Trice Medical, 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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