FDA 510(k)

Velocity Alpha 高速手术钻系统

K号: K253772 · 2026-03-06

决定日期2026-03-06

产品代码HBB

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决定实质等同

器械摘要

Velocity Alpha MR High Speed 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 2026-03-06 under 510(k) number K253772. The device is classified under product code HBB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Velocity Alpha MR High Speed Surgical Drill System?

Velocity Alpha MR High Speed Surgical Drill System is a medical device that received FDA 510(k) clearance on 2026-03-06. The listed applicant is Adeor Medical AG. The 510(k) number is K253772.

When did Velocity Alpha MR High Speed Surgical Drill System receive FDA 510(k) clearance?

Velocity Alpha MR High Speed Surgical Drill System received FDA 510(k) clearance on 2026-03-06, under 510(k) number K253772.

Who is the listed applicant for Velocity Alpha MR High Speed 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 MR High Speed Surgical Drill System?

The FDA product code for Velocity Alpha MR High Speed Surgical Drill System is HBB.

列明Adeor Medical AG为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K191479Velocity Alpha 高速外科钻削系统 K191847Adeor医疗nxt非粘性双极镊子，Adeor医疗nxt一次性非粘性双极镊子

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。