FDA 510(k)

Libertas – 縮窄式非骨水泥股骨柄

K 號：K183684 · 2019-08-23

決定日期2019-08-23

產品代碼LZO

諮詢委員會或

決定相當於

器材摘要

Libertas – Taper Uncemented Femoral Stem 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 2019-08-23 under 510(k) number K183684. 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 – Taper Uncemented Femoral Stem?

Libertas – Taper Uncemented Femoral Stem is a medical device that received FDA 510(k) clearance on 2019-08-23. The listed applicant is Maxx Orthopedics, Inc.. The 510(k) number is K183684.

When did Libertas – Taper Uncemented Femoral Stem receive FDA 510(k) clearance?

Libertas – Taper Uncemented Femoral Stem received FDA 510(k) clearance on 2019-08-23, under 510(k) number K183684.

Who is the listed applicant for Libertas – Taper Uncemented Femoral Stem?

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 – Taper Uncemented Femoral Stem?

The FDA product code for Libertas – Taper Uncemented Femoral Stem 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

查看所有 19 項裝置 →

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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。