The following data is part of a premarket notification filed by Ortho Kinematics, Inc. with the FDA for The Kinegraph Vma (vertebral Motion Analyzer) Software Version 2.2, The Motion Normalizer Patient Handling And Data.
| Device ID | K133875 |
| 510k Number | K133875 |
| Device Name: | THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2, THE MOTION NORMALIZER PATIENT HANDLING AND DATA |
| Classification | System, Image Processing, Radiological |
| Applicant | ORTHO KINEMATICS, INC. 555 13TH STREET, NW Washington, DC 20004 |
| Contact | John J Smith |
| Correspondent | John J Smith ORTHO KINEMATICS, INC. 555 13TH STREET, NW Washington, DC 20004 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-20 |
| Decision Date | 2014-01-17 |
| Summary: | summary |