FDA 510(k)

Velocity Alpha Highspeed Surgical Drill System

K-Number: K191479 · 2021-04-11

Decision Date2021-04-11

Product CodeHBE

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Velocity Alpha Highspeed Surgical Drill System is the device name listed in this FDA 510(k) record. The listed applicant is Adeor Medical AG. It received FDA 510(k) clearance on 2021-04-11 under 510(k) number K191479. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Velocity Alpha Highspeed Surgical Drill System?

Velocity Alpha Highspeed Surgical Drill System is a medical device that received FDA 510(k) clearance on 2021-04-11. The listed applicant is Adeor Medical AG. The 510(k) number is K191479.

When did Velocity Alpha Highspeed Surgical Drill System receive FDA 510(k) clearance?

Velocity Alpha Highspeed Surgical Drill System received FDA 510(k) clearance on 2021-04-11, under 510(k) number K191479.

Who is the listed applicant for Velocity Alpha Highspeed Surgical Drill System?

The FDA 510(k) record lists Adeor Medical AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Velocity Alpha Highspeed Surgical Drill System?

The FDA product code for Velocity Alpha Highspeed Surgical Drill System is HBE.

Other records listing Adeor Medical AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253772Velocity Alpha MR High Speed Surgical Drill System K191847Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use Non-stick Bipolar Forceps

Related Devices (Code: HBE)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.