FDA 510(k)

進步骨科公司全膝系統II

K 號：K183344 · 2019-03-18

申請人The Progressive Orthopaedic Company, LLC

決定日期2019-03-18

產品代碼JWH

諮詢委員會或

決定相當於

器材摘要

The Progressive Orthopaedic Company Total Knee System II 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 2019-03-18 under 510(k) number K183344. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the The Progressive Orthopaedic Company Total Knee System II?

The Progressive Orthopaedic Company Total Knee System II is a medical device that received FDA 510(k) clearance on 2019-03-18. The listed applicant is The Progressive Orthopaedic Company, LLC. The 510(k) number is K183344.

When did The Progressive Orthopaedic Company Total Knee System II receive FDA 510(k) clearance?

The Progressive Orthopaedic Company Total Knee System II received FDA 510(k) clearance on 2019-03-18, under 510(k) number K183344.

Who is the listed applicant for The Progressive Orthopaedic Company Total Knee System II?

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 Company Total Knee System II?

The FDA product code for The Progressive Orthopaedic Company Total Knee System II is JWH.

其他以 The Progressive Orthopaedic Company, LLC 為申請人之記錄

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K151424進步骨科全髋關節系統

相關器械（代碼：JWH）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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