FDA 510(k)

樹突延伸線 (USTAR II 系統)

K 號：K252303 · 2025-08-22

決定日期2025-08-22

產品代碼KRO

諮詢委員會或

決定相當於

器材摘要

Stem Extension Line (USTAR II System) 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 2025-08-22 under 510(k) number K252303. The device is classified under product code KRO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Stem Extension Line (USTAR II System)?

Stem Extension Line (USTAR II System) is a medical device that received FDA 510(k) clearance on 2025-08-22. The listed applicant is United Orthopedic Corporation. The 510(k) number is K252303.

When did Stem Extension Line (USTAR II System) receive FDA 510(k) clearance?

Stem Extension Line (USTAR II System) received FDA 510(k) clearance on 2025-08-22, under 510(k) number K252303.

Who is the listed applicant for Stem Extension Line (USTAR II System)?

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 Stem Extension Line (USTAR II System)?

The FDA product code for Stem Extension Line (USTAR II System) is KRO.

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)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 K243024細膠骨膝間隔

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相關器械（代碼：KRO）

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。

K261898Triathlon® 過膝系統；Triathlon® 開合膝關節系統；Scorpio® 全膝系統Howmedica Osteonics Corp. dba Stryker Orthopaedics K252898Triathlon® Tritanium® 非對稱膝蓋；Triathlon® 對稱膝蓋；Triathlon® 對稱膝蓋；Triathlon® 非對稱膝蓋；Scorpio® 適用型圓頂膝蓋；Triathlon® 鍵盤緩震器Howmedica Osteonics Corp., Dba Stryker Orthopaedics K251665Triathlon® 開合膝關節系統Howmedica Osteonics Corp., Dba Stryker Orthopaedics K242871ATTUNE® Revision Hinge KneeDepuy Ireland UC K240043EVOLUTION® 鍵節膝關節系統；GUARDIAN™ 肢體挽救系統；DCW 模組化遠端股骨系統；REPIPHYSIS™ 肢體挽救系統；EVOLUTION® MP 總膝關節系統；EVOLUTION® MP 總膝關節系統；EVOLUTION® MP 自適應 CS 插件；EVOLUTION® MP 自適應 PS 胫骨插件；EVOLUTION® MP CS/CR 多孔股骨/EVOLUTION® 自適應 CS 和 PS 插件；EVOLUTION® 更新 CCK 系統；ADVANCE® 雙高插件；ADVANCE® A-CLASS® 胫骨插件；ADVANCE® 膝關節系統；ADVANCE® 超共軛胫骨插件Microport Orthopedics, Inc.K233980ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee SystemDepuy Ireland UC

官方來源

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