FDA 510(k)

コンパニオン・スパイン DIAM™ 機器器材

K番号: K253118 · 2025-12-16

決定日2025-12-16

製品コードQLR

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

Companion Spine DIAM™ Instrumentation is the device name listed in this FDA 510(k) record. The listed applicant is Companion Spine France. It received FDA 510(k) clearance on 2025-12-16 under 510(k) number K253118. The device is classified under product code QLR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Companion Spine DIAM™ Instrumentation?

Companion Spine DIAM™ Instrumentation is a medical device that received FDA 510(k) clearance on 2025-12-16. The listed applicant is Companion Spine France. The 510(k) number is K253118.

When did Companion Spine DIAM™ Instrumentation receive FDA 510(k) clearance?

Companion Spine DIAM™ Instrumentation received FDA 510(k) clearance on 2025-12-16, under 510(k) number K253118.

Who is the listed applicant for Companion Spine DIAM™ Instrumentation?

The FDA 510(k) record lists Companion Spine France as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Companion Spine DIAM™ Instrumentation?

The FDA product code for Companion Spine DIAM™ Instrumentation is QLR.

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医療機器の概要

よくある質問

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