FDA 510(k)

EXETER 中心化器，EXETER 2.5mm 插頭

K 號：K191414 · 2019-08-28

決定日期2019-08-28

產品代碼JDI

諮詢委員會或

決定相當於

器材摘要

EXETER Centralizer, EXETER 2.5mm Plug is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Orthopaedics. It received FDA 510(k) clearance on 2019-08-28 under 510(k) number K191414. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EXETER Centralizer, EXETER 2.5mm Plug?

EXETER Centralizer, EXETER 2.5mm Plug is a medical device that received FDA 510(k) clearance on 2019-08-28. The listed applicant is Stryker Orthopaedics. The 510(k) number is K191414.

When did EXETER Centralizer, EXETER 2.5mm Plug receive FDA 510(k) clearance?

EXETER Centralizer, EXETER 2.5mm Plug received FDA 510(k) clearance on 2019-08-28, under 510(k) number K191414.

Who is the listed applicant for EXETER Centralizer, EXETER 2.5mm Plug?

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

What is the FDA product code for EXETER Centralizer, EXETER 2.5mm Plug?

The FDA product code for EXETER Centralizer, EXETER 2.5mm Plug is JDI.

其他以 Stryker Orthopaedics 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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