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Sign in to claim this brandORTHO KINEMATICS, INC.
US
Last updated May 31, 2026
Information
- Country
- US
- Address
- —
- Website
- xx.xx
- —
- —
- [email protected]
- Phone
- 5123345490
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 932053221
Catalogue (13)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| VMA Motion Normalizer | 3 | FDA UDI | Class II | Active |
| VMA DataLink Software | 3 | FDA UDI | Class II | Active |
| Profile-ESP Radiographic marker | 3.0 | FDA UDI | Class I | Active |
| VMA Image Acquisition Software | 3 | FDA UDI | Class II | Active |
| VMA DataLink Software | 2.3 | FDA UDI | Class II | Active |
| Vma | 2 | FDA UDI | Class II | Active |
| Profile-ESP Bolster | 3.0 | FDA UDI | Class I | Active |
| Surgical Planning Software version 1.1 | K173247 | FDA 510(k) | Class II | Active |
| OKI Surgical Planning Software | K171617 | FDA 510(k) | Class II | Active |
| The Kinegraph Vma (vertebral Motion Analyzer) Software Version 2.2, The Motion Normalizer Patient Handling And Data | K133875 | FDA 510(k) | Class II | Active |
| The Kinegraph Vma (vertebral Motion Analyzer) Software Version 2.0; The Motion Normalizer Patient Handling And Data Coll | K130743 | FDA 510(k) | Class II | Active |
| VMA™ System version 3.0 | K172327 | FDA 510(k) | Class II | Active |
| The Kinegraph Vma Software, The Motion Normalizer Patient Handling And Data Collection Device | K112109 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Recalls (4)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| May 23, 2018 | Z-2889-2018 | — | open, classified | This email is to provide notification that, due to a software bug that has been corrected, the Radiological Read Report for the VMA test(s) contained an error. |
| Mar 2, 2017 | Z-2891-2018 | — | open, classified | Ortho Kinematics notified customers that errors were contained in Radiological Read Report and VMA Report for the VMA test. The error resulted from an administrative error of VMA user account settings and has been fixed. |
| Jan 11, 2017 | Z-2882-2018 | — | open, classified | Ortho Kinematics Inc. sent a Notice of Correction to Released Testing Results, Radiological Read Report for the Vertebral Motion Analyzer (VMA) test because it contained an error. The error occurred due to a software bug that has been corrected. |
| Aug 12, 2016 | Z-2890-2018 | — | open, classified | Ortho Kinematics, Inc. notified customers of erroneous results of VMA tests due to a software bug that has been corrected. |