FDA 510(k)

Triathlon® 鍵節膝關節系統；Triathlon® 修復插片 X3®

K 號：K230416 · 2023-05-19

決定日期2023-05-19

產品代碼KRO

諮詢委員會或

決定相當於

器材摘要

Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® is the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2023-05-19 under 510(k) number K230416. 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 Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®?

Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® is a medical device that received FDA 510(k) clearance on 2023-05-19. The listed applicant is Stryker. The 510(k) number is K230416.

When did Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® receive FDA 510(k) clearance?

Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® received FDA 510(k) clearance on 2023-05-19, under 510(k) number K230416.

Who is the listed applicant for Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®?

The FDA 510(k) record lists Stryker as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®?

The FDA product code for Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® is KRO.

其他以 Stryker 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：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 K252303樹突延伸線 (USTAR II 系統)United Orthopedic Corporation 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.

官方來源

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