FDA 510(k)

Advantage-C PEEK Cervical lnterbody Fusion Device

K番号: K211501 · 2021-08-24

決定日2021-08-24

製品コードODP

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

Advantage-C PEEK Cervical lnterbody Fusion Device is the device name listed in this FDA 510(k) record. The listed applicant is Lntelivation, LLC. It received FDA 510(k) clearance on 2021-08-24 under 510(k) number K211501. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Advantage-C PEEK Cervical lnterbody Fusion Device?

Advantage-C PEEK Cervical lnterbody Fusion Device is a medical device that received FDA 510(k) clearance on 2021-08-24. The listed applicant is Lntelivation, LLC. The 510(k) number is K211501.

When did Advantage-C PEEK Cervical lnterbody Fusion Device receive FDA 510(k) clearance?

Advantage-C PEEK Cervical lnterbody Fusion Device received FDA 510(k) clearance on 2021-08-24, under 510(k) number K211501.

Who is the listed applicant for Advantage-C PEEK Cervical lnterbody Fusion Device?

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

What is the FDA product code for Advantage-C PEEK Cervical lnterbody Fusion Device?

The FDA product code for Advantage-C PEEK Cervical lnterbody Fusion Device is ODP.

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Advantage-C PEEK Cervical lnterbody Fusion Device

医療機器の概要

よくある質問

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