Velocity Alpha Highspeed Surgical Drill System

Drills, Burrs, Trephines & Accessories (simple, Powered)

Adeor Medical AG

The following data is part of a premarket notification filed by Adeor Medical Ag with the FDA for Velocity Alpha Highspeed Surgical Drill System.

Pre-market Notification Details

Device IDK191479
510k NumberK191479
Device Name:Velocity Alpha Highspeed Surgical Drill System
ClassificationDrills, Burrs, Trephines & Accessories (simple, Powered)
Applicant adeor Medical AG Biberger Str. 93 Unterhaching,  DE 82008
ContactViktor Rundel
CorrespondentUlrike Winkler
adeor Medical AG Biberger Str. 93 Unterhaching,  DE 82008
Product CodeHBE  
CFR Regulation Number882.4310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-04
Decision Date2021-04-11

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