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FDA 510(k)

進步骨科全髋關節系統

K 號：K151424 · 2016-07-27

申請人The Progressive Orthopaedic Company, LLC
決定日期2016-07-27
產品代碼LPH
諮詢委員會或
決定相當於

器材摘要

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.

常見問題

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.

相關臨床試驗

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NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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

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。

K183344進步骨科公司全膝系統II

相關器械（代碼：LPH）

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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