FDA 510(k)

Z1 硬化股骨システム

K番号: K241241 · 2024-08-27

決定日2024-08-27

製品コードLZO

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

Z1 Cemented Hip System is the device name listed in this FDA 510(k) record. The listed applicant is Orchard Medical Development, LLC. It received FDA 510(k) clearance on 2024-08-27 under 510(k) number K241241. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Z1 Cemented Hip System?

Z1 Cemented Hip System is a medical device that received FDA 510(k) clearance on 2024-08-27. The listed applicant is Orchard Medical Development, LLC. The 510(k) number is K241241.

When did Z1 Cemented Hip System receive FDA 510(k) clearance?

Z1 Cemented Hip System received FDA 510(k) clearance on 2024-08-27, under 510(k) number K241241.

Who is the listed applicant for Z1 Cemented Hip System?

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

What is the FDA product code for Z1 Cemented Hip System?

The FDA product code for Z1 Cemented Hip System is LZO.

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Z1 硬化股骨システム

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：LZO）

公式ソース