FDA 510(k)

Accu-Joint Hemi インプラント

K番号: K200951 · 2020-12-08

決定日2020-12-08

製品コードKWD

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

Accu-Joint Hemi Implant is the device name listed in this FDA 510(k) record. The listed applicant is Accufix Surgical, Inc.. It received FDA 510(k) clearance on 2020-12-08 under 510(k) number K200951. The device is classified under product code KWD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Accu-Joint Hemi Implant?

Accu-Joint Hemi Implant is a medical device that received FDA 510(k) clearance on 2020-12-08. The listed applicant is Accufix Surgical, Inc.. The 510(k) number is K200951.

When did Accu-Joint Hemi Implant receive FDA 510(k) clearance?

Accu-Joint Hemi Implant received FDA 510(k) clearance on 2020-12-08, under 510(k) number K200951.

Who is the listed applicant for Accu-Joint Hemi Implant?

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

What is the FDA product code for Accu-Joint Hemi Implant?

The FDA product code for Accu-Joint Hemi Implant is KWD.

申請者としてAccufix Surgical, Inc.を記載するその他の記録

K240268Accu-Joint Hemi インプラント

公式ソース

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