FDA 510(k) Applications Submitted by Diana Langham
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K220197 |
01/24/2022 |
Trigon HA Wedge Fixation System |
Nvision Biomedical Technologies, Inc |
| K210424 |
02/11/2021 |
Quantum Anterior Cervical Plate |
Nvision Biomedical Technologies, Inc. |
| K190380 |
02/19/2019 |
nvc |
Nvision Biomedical Technologies, Inc. |
| K180458 |
02/20/2018 |
FOCUS Pedicle Screw System |
Nvision Biomedical Technologies, LLC |
| K200428 |
02/21/2020 |
Multi-Drive Interference Screw System |
Nvision Biomedical Technologies, Inc |
| K230853 |
03/28/2023 |
EARP Nerve Cuff Electrode |
Nvision Biomedical Technologies, Inc. |
| K200914 |
04/06/2020 |
Healix Compression Screw System |
Nvision Biomedical Technologies, Inc |
| K211650 |
05/28/2021 |
The Radian MIS Bunion System |
Nvision Biomedical Technologies, Inc |
| K201850 |
07/06/2020 |
Vector Hammertoe Correction System |
Nvision Biomedical Technologies, Inc |
| K222015 |
07/08/2022 |
Integral Titanium Cervical Interbody |
Nvision Biomedical Technologies, Inc |
| K212477 |
08/09/2021 |
EARP Interbody System |
Nvision Biomedical Technologies, Inc. |
| K202657 |
09/14/2020 |
Javelin Tailor's Bunion Fixation System |
Nvision Biomedical Technologies, Inc |
| K192645 |
09/24/2019 |
TrigonÖ Ti Stand-Alone Wedge Fixation System |
Nvision Biomedical Technologies, Inc. |
| K223226 |
10/18/2022 |
TrigonÖ HA Stand-Alone Wedge Fixation System |
Nvision Biomedical Technologies, Inc. |
| K213421 |
10/20/2021 |
Vector« Hammertoe Correction System |
Nvision Biomedical Technologies, Inc |
| K182943 |
10/23/2018 |
VERTEX Nitinol Staple System |
Nvision Biomedical Technologies, LLC |
| K182949 |
10/23/2018 |
HealixÖ Compression Screw System |
Nvision Biomedical Technologies, LLC |
| K183055 |
11/02/2018 |
Vector Hammertoe Correction System |
Nvision Biomedical Technologies, LLC |
| K203445 |
11/23/2020 |
Trigon HA Stand-Alone Wedge Fixation System |
Nvision Biomedical Technologies, Inc. |
| K193414 |
12/09/2019 |
Trigon HA Stand-Alone Wedge Fixation System |
Nvision Biomedical Technologies, Inc |
| K193645 |
12/30/2019 |
nva, nvp, and nvt |
Nvision Biomedical Technologies, Inc. |
| K170074 |
01/09/2017 |
nvc |
Nvision Biomedical Technologies, LLC |
| K161524 |
06/02/2016 |
Tangis Anterior Cervical Plate |
NVISION BIOMEDICAL TECHNOLOGIES, LLC |
| K162426 |
08/30/2016 |
nva, nvp, and nvt |
NVISION BIOMEDICAL TECHNOLOGIES, LLC |
| K173091 |
09/29/2017 |
Boundary Anterior Lumbar Buttress Plate |
Nvision Biomedical Technologies, LLC |
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