FDA 510(k)

Escalade Legend 髋臼殼

K 號：K161080 · 2016-05-17

決定日期2016-05-17

產品代碼LPH

諮詢委員會或

決定相當於

器材摘要

Escalade Legend Acetabular Shell is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Development Corporation. It received FDA 510(k) clearance on 2016-05-17 under 510(k) number K161080. 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 Escalade Legend Acetabular Shell?

Escalade Legend Acetabular Shell is a medical device that received FDA 510(k) clearance on 2016-05-17. The listed applicant is Ortho Development Corporation. The 510(k) number is K161080.

When did Escalade Legend Acetabular Shell receive FDA 510(k) clearance?

Escalade Legend Acetabular Shell received FDA 510(k) clearance on 2016-05-17, under 510(k) number K161080.

Who is the listed applicant for Escalade Legend Acetabular Shell?

The FDA 510(k) record lists Ortho Development Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Escalade Legend Acetabular Shell?

The FDA product code for Escalade Legend Acetabular Shell is LPH.

其他以 Ortho Development Corporation 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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