FDA 510(k)

Artisan ボーンプラグ、ユニバーサルケメントリストレクター

K番号: K220838 · 2022-05-20

申請者Howmedica Osteonics, Dba Stryker Orthopaedics

決定日2022-05-20

製品コードLZN

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

Artisan Bone Plug, Universal Cement Restrictor is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics, Dba Stryker Orthopaedics. It received FDA 510(k) clearance on 2022-05-20 under 510(k) number K220838. The device is classified under product code LZN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Artisan Bone Plug, Universal Cement Restrictor?

Artisan Bone Plug, Universal Cement Restrictor is a medical device that received FDA 510(k) clearance on 2022-05-20. The listed applicant is Howmedica Osteonics, Dba Stryker Orthopaedics. The 510(k) number is K220838.

When did Artisan Bone Plug, Universal Cement Restrictor receive FDA 510(k) clearance?

Artisan Bone Plug, Universal Cement Restrictor received FDA 510(k) clearance on 2022-05-20, under 510(k) number K220838.

Who is the listed applicant for Artisan Bone Plug, Universal Cement Restrictor?

The FDA 510(k) record lists Howmedica Osteonics, Dba Stryker Orthopaedics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Artisan Bone Plug, Universal Cement Restrictor?

The FDA product code for Artisan Bone Plug, Universal Cement Restrictor is LZN.

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医療機器の概要

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