FDA 510(k)

自由骨盆蓋覆蓋內襯

K 號：K183365 · 2019-02-22

決定日期2019-02-22

產品代碼LZO

諮詢委員會或

決定相當於

器材摘要

Libertas Acetabular Hooded 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 2019-02-22 under 510(k) number K183365. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Libertas Acetabular Hooded Liner?

Libertas Acetabular Hooded Liner is a medical device that received FDA 510(k) clearance on 2019-02-22. The listed applicant is Maxx Orthopedics, Inc.. The 510(k) number is K183365.

When did Libertas Acetabular Hooded Liner receive FDA 510(k) clearance?

Libertas Acetabular Hooded Liner received FDA 510(k) clearance on 2019-02-22, under 510(k) number K183365.

Who is the listed applicant for Libertas Acetabular Hooded 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 Acetabular Hooded Liner?

The FDA product code for Libertas Acetabular Hooded Liner is LZO.

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。

K261563自由全膝系統（E-Poly 股骨內襯）K261609自由部分膝關節系統 K253171Libertas 縮窄短 (TS) 未固定股骨柄 (Libertas TS 柄)K252777自由骨顯隆起植入物（骨顯隆起針）K253314自由無限™ 全膝系統 K253144Freedom® 全膝系統 – Titan PCK 零件

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相關器械（代碼：LZO）

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。

K260173M-Vizion 髋關節更換系統擴充版Medacta International S.A.K253948動力骨盂杯系統United Orthopedic Corporation K261009MobileLink 骨盆杯系統 – 40mm ID 插片（各種）Waldemar Link GmbH & Co. KG K260831Z1 髋關節系統Zimmer, Inc.K260182Avenir® Müller 植入物；Avenir Complete™ 髋關節系統Zimmer, Inc.K260037植入式醫療設備包裝系統更新Implantcast GmbH

官方來源

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