FDA 510(k)

卡麥遜部分膝關節

K 號：K251771 · 2025-12-16

決定日期2025-12-16

產品代碼HSX

諮詢委員會或

決定相當於

器材摘要

Cambridge Partial Knee is the device name listed in this FDA 510(k) record. The listed applicant is Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2025-12-16 under 510(k) number K251771. 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 Cambridge Partial Knee?

Cambridge Partial Knee is a medical device that received FDA 510(k) clearance on 2025-12-16. The listed applicant is Signature Orthopaedics Pty, Ltd.. The 510(k) number is K251771.

When did Cambridge Partial Knee receive FDA 510(k) clearance?

Cambridge Partial Knee received FDA 510(k) clearance on 2025-12-16, under 510(k) number K251771.

Who is the listed applicant for Cambridge Partial Knee?

The FDA 510(k) record lists Signature Orthopaedics Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cambridge Partial Knee?

The FDA product code for Cambridge Partial Knee is HSX.

其他以 Signature Orthopaedics Pty, Ltd. 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。

K261609自由部分膝關節系統Maxx Orthopedics, Inc.K260796塔霍聯合單關節膝關節系統，配以TiNbN覆層Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics K251834人體部分膝蓋Zimmer Biomet K251618MOTO 部分膝關節系統擴充版Medacta International S.A.K251453Arthrex iBalance 部分膝關節系統Arthrex, Inc.K241260ACTIFY™ 单髁膝关节系統Globus Medical, Inc.

官方來源

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