FDA 510(k)

M6-C 人間工学頸椎ディスク器具 AS

K番号: K220861 · 2022-06-02

決定日2022-06-02

製品コードQLQ

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OR [翻訳] OR 注：原文が具体的な内容を含んでいないため、翻訳は単なる「OR」のままです。

決定大幅同等

医療機器の概要

M6-C Artificial Cervical Disc Instruments AS is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Kinetics, LLC. It received FDA 510(k) clearance on 2022-06-02 under 510(k) number K220861. The device is classified under product code QLQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the M6-C Artificial Cervical Disc Instruments AS?

M6-C Artificial Cervical Disc Instruments AS is a medical device that received FDA 510(k) clearance on 2022-06-02. The listed applicant is Spinal Kinetics, LLC. The 510(k) number is K220861.

When did M6-C Artificial Cervical Disc Instruments AS receive FDA 510(k) clearance?

M6-C Artificial Cervical Disc Instruments AS received FDA 510(k) clearance on 2022-06-02, under 510(k) number K220861.

Who is the listed applicant for M6-C Artificial Cervical Disc Instruments AS?

The FDA 510(k) record lists Spinal Kinetics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for M6-C Artificial Cervical Disc Instruments AS?

The FDA product code for M6-C Artificial Cervical Disc Instruments AS is QLQ.

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M6-C 人間工学頸椎ディスク器具 AS

医療機器の概要

よくある質問

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