FDA 510(k)

リスポンシブ・オルシス・全髋関節形成術システム

K番号: K163585 · 2017-06-02

決定日2017-06-02

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

Responsive Orthopedics Total Hip Arthroplasty System is the device name listed in this FDA 510(k) record. The listed applicant is Responsive Orthopedics, LLC. It received FDA 510(k) clearance on 2017-06-02 under 510(k) number K163585. 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 Responsive Orthopedics Total Hip Arthroplasty System?

Responsive Orthopedics Total Hip Arthroplasty System is a medical device that received FDA 510(k) clearance on 2017-06-02. The listed applicant is Responsive Orthopedics, LLC. The 510(k) number is K163585.

When did Responsive Orthopedics Total Hip Arthroplasty System receive FDA 510(k) clearance?

Responsive Orthopedics Total Hip Arthroplasty System received FDA 510(k) clearance on 2017-06-02, under 510(k) number K163585.

Who is the listed applicant for Responsive Orthopedics Total Hip Arthroplasty System?

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

What is the FDA product code for Responsive Orthopedics Total Hip Arthroplasty System?

The FDA product code for Responsive Orthopedics Total Hip Arthroplasty System is LZO.

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リスポンシブ・オルシス・全髋関節形成術システム

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