Ortho Kinematics, Inc
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 6
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2889-2018 | Class II | Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiological | May 23, 2018 |
| Z-2891-2018 | Class II | Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254. Product Usage: VMA software is a quantitativ | March 2, 2017 |
| Z-2882-2018 | Class II | Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software | January 11, 2017 |
| Z-2890-2018 | Class II | Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232. Product Usage: VMA sof | August 12, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K173247 | Surgical Planning Software version 1.1 | November 8, 2017 |
| K172327 | VMA System version 3.0 | August 25, 2017 |
| K171617 | OKI Surgical Planning Software | August 22, 2017 |
| K133875 | THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2, THE MOTION NORMALIZER PATIENT HA | January 17, 2014 |
| K130743 | THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.0; THE MOTION NORMALIZER PATIENT HA | August 6, 2013 |
| K112109 | THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLECTION DEVICE | December 22, 2011 |