FDA 510(k)

Artus™ cervical plate system

K番号: K202227 · 2020-09-14

決定日2020-09-14

製品コードKWQ

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

Artus™ cervical plate system is the device name listed in this FDA 510(k) record. The listed applicant is Ulrich GmbH & Co. KG. It received FDA 510(k) clearance on 2020-09-14 under 510(k) number K202227. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Artus™ cervical plate system?

Artus™ cervical plate system is a medical device that received FDA 510(k) clearance on 2020-09-14. The listed applicant is Ulrich GmbH & Co. KG. The 510(k) number is K202227.

When did Artus™ cervical plate system receive FDA 510(k) clearance?

Artus™ cervical plate system received FDA 510(k) clearance on 2020-09-14, under 510(k) number K202227.

Who is the listed applicant for Artus™ cervical plate system?

The FDA 510(k) record lists Ulrich GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Artus™ cervical plate system?

The FDA product code for Artus™ cervical plate system is KWQ.

申請者としてUlrich GmbH & Co. KGを記載するその他の記録

K252281ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)K251295ulrichINJECT CT Motion (XD 8000)K241850ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)K233737ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)K210541ulrichINJECT CT motion K192872ulrichINJECT CT Motion

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