FDA 510(k)

萊格德® 骨盆杯

K 號：K242833 · 2024-10-11

決定日期2024-10-11

產品代碼LPH

諮詢委員會或

決定相當於

器材摘要

Legend® Acetabular Shell is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Development Corp.. It received FDA 510(k) clearance on 2024-10-11 under 510(k) number K242833. 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 Legend® Acetabular Shell?

Legend® Acetabular Shell is a medical device that received FDA 510(k) clearance on 2024-10-11. The listed applicant is Ortho Development Corp.. The 510(k) number is K242833.

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

Legend® Acetabular Shell received FDA 510(k) clearance on 2024-10-11, under 510(k) number K242833.

Who is the listed applicant for Legend® Acetabular Shell?

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

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

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

其他以 Ortho Development Corp. 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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