The following data is part of a premarket notification filed by Ortho Kinematics, Inc. with the FDA for Vma™ System Version 3.0.
| Device ID | K172327 |
| 510k Number | K172327 |
| Device Name: | VMA™ System Version 3.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | Ortho Kinematics, Inc. 110 Wild Basin Road, Suite 250 Austin, TX 78704 |
| Contact | Adam Deitz |
| Correspondent | John J. Smith Hogan Lovells US LLP. 555 13th Street, NW Washington, DC 20004 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-01 |
| Decision Date | 2017-08-25 |
| Summary: | summary |