FDA 510(k)

自由人工關節置換系統

K 號：K180973 · 2018-09-28

決定日期2018-09-28

產品代碼JDI

諮詢委員會或

決定相當於

器材摘要

Libertas Hip Replacement System 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 2018-09-28 under 510(k) number K180973. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Libertas Hip Replacement System?

Libertas Hip Replacement System is a medical device that received FDA 510(k) clearance on 2018-09-28. The listed applicant is Maxx Orthopedics, Inc.. The 510(k) number is K180973.

When did Libertas Hip Replacement System receive FDA 510(k) clearance?

Libertas Hip Replacement System received FDA 510(k) clearance on 2018-09-28, under 510(k) number K180973.

Who is the listed applicant for Libertas Hip Replacement System?

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 Hip Replacement System?

The FDA product code for Libertas Hip Replacement System is JDI.

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：JDI）

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。

K253515Zimmer Biomet OSS™ 骨科救傷系統 OsseoTi® 穿孔套管及增強件Biomet Orthopedics, Inc.K253434OSSTM 骨科救護系統Biomet, Inc.K252824Evolve AP杯，世界鳍杯，世界G-Zero Liner及奇數球頭Signature Orthopaedics Pty, Ltd.K243571trabecular金屬骨盆修復系統，骨盆內襯及限制性內襯Zimmer Biomet K240783Anthology 髋部釘；CPCS 髋部釘；股骨頭；R3 骨盆蓋內衬；Spectron 髋部釘；Synergy 髋部釘Smith & Nephew, Inc.K241716全球模組化更換系統，模組化更換系統，模組化旋轉軸承膝關節元件Howmedica Osteonics Corp., Dba Stryker Orthopaedics

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