FDA 510(k)

Klassic HD 髋關節系統

K 號：K161073 · 2016-10-19

決定日期2016-10-19

產品代碼LPH

諮詢委員會或

決定相當於

器材摘要

Klassic HD Hip System is the device name listed in this FDA 510(k) record. The listed applicant is Total Joint Othopedics, Inc.. It received FDA 510(k) clearance on 2016-10-19 under 510(k) number K161073. 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 Klassic HD Hip System?

Klassic HD Hip System is a medical device that received FDA 510(k) clearance on 2016-10-19. The listed applicant is Total Joint Othopedics, Inc.. The 510(k) number is K161073.

When did Klassic HD Hip System receive FDA 510(k) clearance?

Klassic HD Hip System received FDA 510(k) clearance on 2016-10-19, under 510(k) number K161073.

Who is the listed applicant for Klassic HD Hip System?

The FDA 510(k) record lists Total Joint Othopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Klassic HD Hip System?

The FDA product code for Klassic HD Hip System is LPH.

其他以 Total Joint Othopedics, Inc. 為申請人之記錄

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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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