FDA 510(k)

自由 E-XLPE 模組化外層

K 號：K192989 · 2020-10-29

決定日期2020-10-29

產品代碼OQI

諮詢委員會或

決定相當於

器材摘要

Libertas E-XLPE Modular Liner is the device name listed in this FDA 510(k) record. The listed applicant is Maxx Orthopedics, Inc.. It received FDA 510(k) clearance on 2020-10-29 under 510(k) number K192989. The device is classified under product code OQI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Libertas E-XLPE Modular Liner?

Libertas E-XLPE Modular Liner is a medical device that received FDA 510(k) clearance on 2020-10-29. The listed applicant is Maxx Orthopedics, Inc.. The 510(k) number is K192989.

When did Libertas E-XLPE Modular Liner receive FDA 510(k) clearance?

Libertas E-XLPE Modular Liner received FDA 510(k) clearance on 2020-10-29, under 510(k) number K192989.

Who is the listed applicant for Libertas E-XLPE Modular Liner?

FDA 510(k) 記錄將 Maxx Orthopedics, Inc. 列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Libertas E-XLPE Modular Liner?

The FDA product code for Libertas E-XLPE Modular Liner is OQI.

其他以 Maxx Orthopedics, Inc. 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。

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相關器械（代碼：OQI）

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。

K252451EPORE® XO 杯系統Implantcast GmbH K172833E-XPE 骨盆组件及 U-Motion II 骨盆杯United Orthopedic Corporation K173583Exactech® Novation® 及 AcuMatch® E-HXL 骨盆蓋內襯Exactech, Inc.

官方來源

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