The following data is part of a premarket notification filed by Adeor Medical Ag with the FDA for Velocity Alpha Highspeed Surgical Drill System.
| Device ID | K191479 |
| 510k Number | K191479 |
| Device Name: | Velocity Alpha Highspeed Surgical Drill System |
| Classification | Drills, Burrs, Trephines & Accessories (simple, Powered) |
| Applicant | adeor Medical AG Biberger Str. 93 Unterhaching, DE 82008 |
| Contact | Viktor Rundel |
| Correspondent | Ulrike Winkler adeor Medical AG Biberger Str. 93 Unterhaching, DE 82008 |
| Product Code | HBE |
| CFR Regulation Number | 882.4310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-04 |
| Decision Date | 2021-04-11 |