FDA 510(k)

Synchfix EVT

K 號：K251643 · 2025-10-29

申請人Wright Medical Technology, Inc. (Stryker Corporation)

決定日期2025-10-29

產品代碼HTN

諮詢委員會或

決定相當於

器材摘要

Synchfix EVT is the device name listed in this FDA 510(k) record. The listed applicant is Wright Medical Technology, Inc. (Stryker Corporation). It received FDA 510(k) clearance on 2025-10-29 under 510(k) number K251643. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Synchfix EVT?

Synchfix EVT is a medical device that received FDA 510(k) clearance on 2025-10-29. The listed applicant is Wright Medical Technology, Inc. (Stryker Corporation). The 510(k) number is K251643.

When did Synchfix EVT receive FDA 510(k) clearance?

Synchfix EVT received FDA 510(k) clearance on 2025-10-29, under 510(k) number K251643.

Who is the listed applicant for Synchfix EVT?

The FDA 510(k) record lists Wright Medical Technology, Inc. (Stryker Corporation) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Synchfix EVT?

The FDA product code for Synchfix EVT is HTN.

其他以 Wright Medical Technology, Inc. (Stryker Corporation) 為申請人之記錄

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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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