Velocity Alpha Highspeed Surgical Drill System

FDA 510(k) K191479 · Adeor Medical AG

Substantially Equivalent

510(k) numberK191479

Submission

Device name
Velocity Alpha Highspeed Surgical Drill System
Applicant
Adeor Medical AG
Unterhaching, DE
Received
June 4, 2019
Decision date
April 11, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HBE – Drills, Burrs, Trephines & Accessories (Simple, Powered)
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4310
Specialty
Neurology

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K252060GreenHBE · Traditional Phasor Health, LLC10/31/2025SE
K252662UniBurHBE · Traditional Nakanishi, Inc.09/19/2025SE
K251433Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…HBE · Special Surgify Medical OY06/04/2025SE
K250380Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…HBE · Special Surgify Medical OY03/13/2025SE
K250374iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round…HBE · Special Stryker Instruments03/11/2025SE
K232684Surgify HaloHBE · Traditional Surgify Medical OY11/29/2023SE
K230619Hubly Electric Drill (H100)HBE · Traditional Hubly, Inc.05/04/2023SE
K2231992.1 x 255mm Drill, 22mm StopHBE · Special Biomet Microfixation11/15/2022SE

More from Biomet Microfixation

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K253772Velocity Alpha MR High Speed Surgical Drill SystemHBB · Traditional 03/06/2026SE
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Questions and answers

When was Velocity Alpha Highspeed Surgical Drill System cleared by the FDA?

Velocity Alpha Highspeed Surgical Drill System (K191479) received a 510(k) decision of Substantially Equivalent on April 11, 2021, 677 days after the submission was received.

What is the product code of K191479?

The FDA product code is HBE – Drills, Burrs, Trephines & Accessories (Simple, Powered), a Class II (moderate risk) device regulated under 21 CFR 882.4310.