This page includes the latest FDA filings for Ortho8 Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3014676071 |
| FEI Number | 3014676071 |
| Name | ORTHO8 INC. |
| Owner & Operator | Ortho8 Inc. |
| Contact Address | 2217 Plaza Dr. Rocklin CA 95765 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 2217 Plaza Dr. Rocklin, CA 95765 US |
Device Company | Device | Date |
|---|---|---|
| Ortho8 Inc | DVT Universal Wrap Extender, Max and Defender | 2022-11-28 |
| Ortho8 Inc | VenaOne, Single Device | 2022-11-28 |
| Ortho8 Inc | Circul8 Max, Pair | 2022-11-28 |
| Ortho8 Inc | VenaOne, Wrap Extenders | 2022-11-28 |
| Ortho8 Inc | VenaOne, Charging Station with Battery Set | 2022-11-28 |
| Ortho8 Inc | Defender, Pair | 2022-11-28 |
| Ortho8 Inc | Luxe DVT, Pair | 2022-11-28 |
| Ortho8 Inc | VenaPro, Pair | 2022-11-28 |
| Ortho8 Inc | Circul8 Pro, Pair | 2022-11-28 |
| Ortho8 Inc | VenaOne, Single Replacement Device | 2022-11-28 |
| Ortho8 Inc | VenaOne, Bulk pack of 20 | 2022-11-28 |
| Ortho8 Inc | VenaOne, Single Disposable Wrap | 2022-11-28 |
| Ortho8 Inc | VenaOne, Pair of Batteries | 2022-11-28 |
| Ortho8 Inc | Circul8 Pro, Extender, Pair | 2022-11-28 |
| Ortho8 Inc | VenaOne, Disposable Wraps, Box of 20 pairs | 2022-11-28 |
| Ortho8 Inc | VenaOne, Pair | 2022-11-28 |
Ortho8, Inc. | CIRCUL8 Connect DVT Prevention Device | 2022-06-03 |
Ortho8 Inc. | CIRCUL8 Luxe DVT Prevention Device | 2021-09-08 |