FDA 510(k)

模組式旋轉軸承膝關節系統及相容零件

K 號：K223069 · 2023-04-21

申請人Howmedica Osteonics Corp., Dba Stryker Orthopaedics

決定日期2023-04-21

產品代碼KRO

諮詢委員會或

決定相當於

器材摘要

Modular Rotating Hinge Knee Systems and Compatible Components is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. It received FDA 510(k) clearance on 2023-04-21 under 510(k) number K223069. 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 Modular Rotating Hinge Knee Systems and Compatible Components?

Modular Rotating Hinge Knee Systems and Compatible Components is a medical device that received FDA 510(k) clearance on 2023-04-21. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The 510(k) number is K223069.

When did Modular Rotating Hinge Knee Systems and Compatible Components receive FDA 510(k) clearance?

Modular Rotating Hinge Knee Systems and Compatible Components received FDA 510(k) clearance on 2023-04-21, under 510(k) number K223069.

Who is the listed applicant for Modular Rotating Hinge Knee Systems and Compatible Components?

The FDA 510(k) record lists Howmedica Osteonics Corp., Dba Stryker Orthopaedics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Modular Rotating Hinge Knee Systems and Compatible Components?

The FDA product code for Modular Rotating Hinge Knee Systems and Compatible Components is KRO.

其他以 Howmedica Osteonics Corp., Dba Stryker Orthopaedics 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。

K261898Triathlon® 過膝系統；Triathlon® 開合膝關節系統；Scorpio® 全膝系統 K261624Omnifit® 20°系列I植入物；Omnifit® Crossfire® 10°系列II植入物；限制性 acetabular 植入物；Trident® Crossfire® 0°聚乙烯植入物；Trident® Crossfire® 10°聚乙烯植入物；System 12 Crossfire® 10°植入物；Trident® 0°限制性 acetabular 植入物；Trident® 限制性 acetabular 线圈；Trident® 全聚乙烯限制性 acetabular 植入物；Crossfire® 偏心植入物 10°；Artisan® 骨栓；UHR® 大頭雙極組件 K253637Triathlon® 全膝系統 - Triathlon® X3® 中間穩定胫骨承插件 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 K252044Triathlon® 全膝系統 - Triathlon® 金屬股骨组件 K251665Triathlon® 開合膝關節系統

查看所有 27 項裝置 →

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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。