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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04251388933916 | K191479 | 000 |
| 04251388939451 | K191479 | 000 |
| 04251388939468 | K191479 | 000 |
| 04251388939475 | K191479 | 000 |
| 04251388939482 | K191479 | 000 |
| 04251388939499 | K191479 | 000 |
| 04251388939864 | K191479 | 000 |
| 04251388939871 | K191479 | 000 |
| 04251388939888 | K191479 | 000 |
| 04251388939444 | K191479 | 000 |
| 04251388939437 | K191479 | 000 |
| 04251388939420 | K191479 | 000 |
| 04251388939321 | K191479 | 000 |
| 04251388939338 | K191479 | 000 |
| 04251388939345 | K191479 | 000 |
| 04251388939352 | K191479 | 000 |
| 04251388939369 | K191479 | 000 |
| 04251388939376 | K191479 | 000 |
| 04251388939406 | K191479 | 000 |
| 04251388939413 | K191479 | 000 |
| 04251388939956 | K191479 | 000 |
| 04251388939987 | K191479 | 000 |
| 04251388942116 | K191479 | 000 |
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| 04251388957134 | K191479 | 000 |
| 04251388957141 | K191479 | 000 |
| 04251388957158 | K191479 | 000 |
| 04251388957165 | K191479 | 000 |
| 04251388957172 | K191479 | 000 |
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| 04251388957097 | K191479 | 000 |
| 04251388956847 | K191479 | 000 |
| 04251388942123 | K191479 | 000 |
| 04251388942130 | K191479 | 000 |
| 04251388955437 | K191479 | 000 |
| 04251388955444 | K191479 | 000 |
| 04251388956786 | K191479 | 000 |
| 04251388956816 | K191479 | 000 |
| 04251388956823 | K191479 | 000 |
| 04251388956830 | K191479 | 000 |
| 04251388939390 | K191479 | 000 |