FDA 510(k) Applications Submitted by Brad Sheals, MS
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K170282 |
01/30/2017 |
Smith & Nephew VISIONAIRE Adaptive Guides |
Smith & Nephew, Inc |
| K130646 |
03/11/2013 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
| K160738 |
03/17/2016 |
ZUK Select Knee System |
SMITH & NEPHEW, INC. |
| K200826 |
03/30/2020 |
Smith&Nephew VISIONAIRE Patient Matched Cutting Blocks |
Smith&Nephew, Inc. |
| K100967 |
04/08/2010 |
PERIMETER C SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
| K251238 |
04/22/2025 |
Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010) |
Maquet Cardiovascular, LLC |
| K211221 |
04/23/2021 |
Porous Patella and Porous Tibia Baseplate |
Smith & Nephew, Inc. |
| K091442 |
05/15/2009 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
| K121760 |
06/15/2012 |
CAPSTONE SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
| K121764 |
06/15/2012 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
| K091797 |
06/17/2009 |
TSRH SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
| K172336 |
08/02/2017 |
Smith & Nephew Patient Matched Cutting Blocks |
Smith & Nephew, Inc. |
| K092325 |
08/04/2009 |
MODIFICATION TO:CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
| K082236 |
08/07/2008 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
| K152315 |
08/17/2015 |
JOURNEY II Uni Tibial Base and Insert |
Smith & Nephew, Inc. |
| K132897 |
09/16/2013 |
CLYDESDALE SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
| K152726 |
09/22/2015 |
JOURNEY II XR Knee System |
SMITH & NEPHEW, INC. |
| K203175 |
10/26/2020 |
POLARSTEM Cemented Femoral Stem |
Smith & Nephew, Inc. |
| K183010 |
10/31/2018 |
Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks |
Smith & Nephew, Inc. |
| K213874 |
12/13/2021 |
MAVERICK External Fixation System |
Smith & Nephew, Inc. |
| K073535 |
12/17/2007 |
BIOFOAM BONE WEDGE |
WRIGHT MEDICAL TECHNOLOGY, INC. |
| K243918 |
12/20/2024 |
Vasoview Hemopro 3 Power Supply |
Maquet Cardiovascular, LLC |
|
|
