FDA 510(k)

鐵人三項PKR X3 靈骨植入物，Mako X3 聯合覆蓋靈骨植入物

K 號：K180612 · 2018-06-07

申請人Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics

決定日期2018-06-07

產品代碼HSX

諮詢委員會或

決定相當於

器材摘要

Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. It received FDA 510(k) clearance on 2018-06-07 under 510(k) number K180612. 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 Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts?

Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts is a medical device that received FDA 510(k) clearance on 2018-06-07. The listed applicant is Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. The 510(k) number is K180612.

When did Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts receive FDA 510(k) clearance?

Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts received FDA 510(k) clearance on 2018-06-07, under 510(k) number K180612.

Who is the listed applicant for Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts?

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

What is the FDA product code for Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts?

The FDA product code for Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts is HSX.

其他以 Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics 為申請人之記錄

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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。

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官方來源

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