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FDA 510(k)

塔霍聯合單關節膝關節系統，配以TiNbN覆層

K 號：K260796 · 2026-04-02

申請人Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics
決定日期2026-04-02
產品代碼HSX
諮詢委員會或
決定相當於

器材摘要

Tahoe Unicondylar Knee System with TiNbN Overcoat is the device name listed in this FDA 510(k) record. The listed applicant is Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics. It received FDA 510(k) clearance on 2026-04-02 under 510(k) number K260796. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Tahoe Unicondylar Knee System with TiNbN Overcoat?

Tahoe Unicondylar Knee System with TiNbN Overcoat is a medical device that received FDA 510(k) clearance on 2026-04-02. The listed applicant is Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics. The 510(k) number is K260796.

When did Tahoe Unicondylar Knee System with TiNbN Overcoat receive FDA 510(k) clearance?

Tahoe Unicondylar Knee System with TiNbN Overcoat received FDA 510(k) clearance on 2026-04-02, under 510(k) number K260796.

Who is the listed applicant for Tahoe Unicondylar Knee System with TiNbN Overcoat?

The FDA 510(k) record lists Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tahoe Unicondylar Knee System with TiNbN Overcoat?

The FDA product code for Tahoe Unicondylar Knee System with TiNbN Overcoat is HSX.

相關臨床試驗

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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其他以 Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics 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：HSX）

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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官方來源

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