FDA 510(k)

Pinnacle Duofix HA 髋關節杯置換體

K 號：K192919 · 2019-11-26

決定日期2019-11-26

產品代碼LPH

諮詢委員會或

決定相當於

器材摘要

Pinnacle Duofix HA Acetabular Cup Prosthesis is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2019-11-26 under 510(k) number K192919. 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 Pinnacle Duofix HA Acetabular Cup Prosthesis?

Pinnacle Duofix HA Acetabular Cup Prosthesis is a medical device that received FDA 510(k) clearance on 2019-11-26. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K192919.

When did Pinnacle Duofix HA Acetabular Cup Prosthesis receive FDA 510(k) clearance?

Pinnacle Duofix HA Acetabular Cup Prosthesis received FDA 510(k) clearance on 2019-11-26, under 510(k) number K192919.

Who is the listed applicant for Pinnacle Duofix HA Acetabular Cup Prosthesis?

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

What is the FDA product code for Pinnacle Duofix HA Acetabular Cup Prosthesis?

The FDA product code for Pinnacle Duofix HA Acetabular Cup Prosthesis is LPH.

其他以 DePuy Orthopaedics, 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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