| Primary Device ID | 00868579000209 |
| NIH Device Record Key | 5abba027-f2f3-4251-82eb-0525771134cc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VMA |
| Version Model Number | 2 |
| Company DUNS | 932053221 |
| Company Name | ORTHO KINEMATICS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 5123345490 |
| xx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00868579000209 [Primary] |
| LLZ | System, Image Processing, Radiological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-02-21 |
| Device Publish Date | 2016-09-22 |
| 00868579000216 - VMA DataLink Software | 2019-05-23 |
| 00868579000223 - VMA DataLink Software | 2019-05-23 VMA DataLink Software (SW4) available to customers on Ortho Kinematics secure site |
| 00868579000230 - VMA Image Acquisition Software | 2019-05-23 VMA Image Acquisition Software (SW1) installed on VMA (Motion Normalizer Console) |
| 00868579000261 - Profile-ESP Bolster | 2019-03-11 The Profile-ESP Bolster device is an optional patient positioning accessory for use within the Profile-ESP workflow of the VMA S |
| 00868579000278 - Profile-ESP Radiographic marker | 2019-03-11 The Profile-ESP Radiographic Marker is an accessory for use within the Profile-ESP workflow of the VMA System. It can facilitate |
| 00868579000209 - VMA | 2019-02-21 |
| 00868579000209 - VMA | 2019-02-21 |
| 00868579000247 - VMA Motion Normalizer | 2019-02-21 VMA Motion Normalizer (Console, Table, and Upright assemblies) |