FDA 510(k)

連結Endo-Model膝關節系統配PorEx（TiNbN）塗層，連結Sled膝關節系統配PorEx（TiNbN）塗層

K 號：K152431 · 2016-05-09

決定日期2016-05-09

產品代碼KRO

諮詢委員會或

決定相當於

器材摘要

LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating is the device name listed in this FDA 510(k) record. The listed applicant is Waldemar Link GmbH & Co. KG. It received FDA 510(k) clearance on 2016-05-09 under 510(k) number K152431. 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 LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating?

LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating is a medical device that received FDA 510(k) clearance on 2016-05-09. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K152431.

When did LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating receive FDA 510(k) clearance?

LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating received FDA 510(k) clearance on 2016-05-09, under 510(k) number K152431.

Who is the listed applicant for LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating?

The FDA 510(k) record lists Waldemar Link GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating?

The FDA product code for LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating is KRO.

其他以 Waldemar Link GmbH & Co. KG 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。

K261009MobileLink 骨盆杯系統 – 40mm ID 插片（各種）K250375Allure骨盆柄和骨髓內插釘 K243927MobileLink 骨盆杯系統 - 自家塗層 K241636MobileLink 骨盆杯系統 - 線路擴展（多個）K231445連結肩部系統 - 反向配置 K222066LINK MobileLink 骨盆杯系統

查看所有 30 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。