FDA 510(k)

進歩的な整形外科全髋関節システム

K番号: K151424 · 2016-07-27

申請者The Progressive Orthopaedic Company, LLC

決定日2016-07-27

製品コードLPH

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

The Progressive Orthopaedic Total Hip System is the device name listed in this FDA 510(k) record. The listed applicant is The Progressive Orthopaedic Company, LLC. It received FDA 510(k) clearance on 2016-07-27 under 510(k) number K151424. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the The Progressive Orthopaedic Total Hip System?

The Progressive Orthopaedic Total Hip System is a medical device that received FDA 510(k) clearance on 2016-07-27. The listed applicant is The Progressive Orthopaedic Company, LLC. The 510(k) number is K151424.

When did The Progressive Orthopaedic Total Hip System receive FDA 510(k) clearance?

The Progressive Orthopaedic Total Hip System received FDA 510(k) clearance on 2016-07-27, under 510(k) number K151424.

Who is the listed applicant for The Progressive Orthopaedic Total Hip System?

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

What is the FDA product code for The Progressive Orthopaedic Total Hip System?

The FDA product code for The Progressive Orthopaedic Total Hip System is LPH.

申請者としてThe Progressive Orthopaedic Company, LLCを記載するその他の記録

K183344進歩的整形外科株式会社全膝システムII

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