FDA 510(k)

trabecular金屬骨盆修復系統，骨盆內襯及限制性內襯

K 號：K243571 · 2025-07-31

決定日期2025-07-31

產品代碼JDI

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器材摘要

Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Biomet. It received FDA 510(k) clearance on 2025-07-31 under 510(k) number K243571. 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 Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners?

Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners is a medical device that received FDA 510(k) clearance on 2025-07-31. The listed applicant is Zimmer Biomet. The 510(k) number is K243571.

When did Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners receive FDA 510(k) clearance?

Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners received FDA 510(k) clearance on 2025-07-31, under 510(k) number K243571.

Who is the listed applicant for Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners?

FDA 510(k) 記錄將 Zimmer Biomet 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners?

The FDA product code for Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners is JDI.

其他以 Zimmer Biomet 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：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.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 K240418Stryker 骨科髋關節系統標籤更新Howmedica Osteonics Corp., Dba Stryker Orthopaedics

官方來源

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