FDA 510(k)

Triathlon® X3® UHMWPE 靈骨植入物及關節頭組件

K 號：K172634 · 2017-11-16

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

決定日期2017-11-16

產品代碼MBH

諮詢委員會或

決定相當於

器材摘要

Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components 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 2017-11-16 under 510(k) number K172634. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components?

Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components is a medical device that received FDA 510(k) clearance on 2017-11-16. The listed applicant is Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. The 510(k) number is K172634.

When did Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components receive FDA 510(k) clearance?

Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components received FDA 510(k) clearance on 2017-11-16, under 510(k) number K172634.

Who is the listed applicant for Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components?

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® X3® UHMWPE Tibial Inserts and Patellar Components?

The FDA product code for Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components is MBH.

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：MBH）

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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