Velocity Alpha Highspeed Surgical Drill System— 510(k) K191479
Substantially EquivalentAdeor Medical AG
FDA 510(k) clearance K191479 for Velocity Alpha Highspeed Surgical Drill System, Substantially Equivalent on 2021-04-11. Applicant: Adeor Medical AG. Device class: 2.
Clearance details
- Applicant
- Adeor Medical AG
- Product code
- Code HBE
- Device class
- Class 2
- Regulation
- 21 CFR 882.4310
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Unterhaching, DE
Recent devices under product code HBE
view allMore clearances from Adeor Medical AG
view allAdverse events under product code HBE
product code HBE- Injury
- 306
- Malfunction
- 7,175
- Other
- 1
- Total
- 7,482
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.