FDA 510(k)

合規骨水泥植入物

K 號：K191056 · 2020-01-03

決定日期2020-01-03

產品代碼JDI

諮詢委員會或

決定相當於

器材摘要

Conformity stem, cemented is the device name listed in this FDA 510(k) record. The listed applicant is United Orthopedic Corporation. It received FDA 510(k) clearance on 2020-01-03 under 510(k) number K191056. 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 Conformity stem, cemented?

Conformity stem, cemented is a medical device that received FDA 510(k) clearance on 2020-01-03. The listed applicant is United Orthopedic Corporation. The 510(k) number is K191056.

When did Conformity stem, cemented receive FDA 510(k) clearance?

Conformity stem, cemented received FDA 510(k) clearance on 2020-01-03, under 510(k) number K191056.

Who is the listed applicant for Conformity stem, cemented?

FDA 510(k) 記錄中將 United Orthopedic Corporation 列為申請人。這並不單獨確立該設備製造商的身份。

What is the FDA product code for Conformity stem, cemented?

The FDA product code for Conformity stem, cemented is JDI.

其他以 United Orthopedic Corporation 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。

K253948動力骨盂杯系統 K252725樹突延伸線 (U2 全膝系統—PSA 型式)K252303樹突延伸線 (USTAR II 系統)K243656U2 全膝系統 – PF+ 髌骨；USTAR II 系統 – PF+ 髌骨 K242315解決模組化修復股骨柄 K243466合規樹枝擴展線，#0

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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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