FDA 510(k)

KeriFlex® MCPおよびPIP指関節プロテーゼ

K番号: K211385 · 2022-07-27

決定日2022-07-27

製品コードKYJ

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

KeriFlex® MCP and PIP Finger Joint Prostheses is the device name listed in this FDA 510(k) record. The listed applicant is Keri Medical SA. It received FDA 510(k) clearance on 2022-07-27 under 510(k) number K211385. The device is classified under product code KYJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the KeriFlex® MCP and PIP Finger Joint Prostheses?

KeriFlex® MCP and PIP Finger Joint Prostheses is a medical device that received FDA 510(k) clearance on 2022-07-27. The listed applicant is Keri Medical SA. The 510(k) number is K211385.

When did KeriFlex® MCP and PIP Finger Joint Prostheses receive FDA 510(k) clearance?

KeriFlex® MCP and PIP Finger Joint Prostheses received FDA 510(k) clearance on 2022-07-27, under 510(k) number K211385.

Who is the listed applicant for KeriFlex® MCP and PIP Finger Joint Prostheses?

The FDA 510(k) record lists Keri Medical SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KeriFlex® MCP and PIP Finger Joint Prostheses?

The FDA product code for KeriFlex® MCP and PIP Finger Joint Prostheses is KYJ.

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。

KeriFlex® MCPおよびPIP指関節プロテーゼ

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：KYJ）

公式ソース