FDA 510(k)

SternaLock 胸骨固定系統

K 號：K212782 · 2022-05-17

決定日期2022-05-17

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

SternaLock Sternal Closure System is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Microfixation. It received FDA 510(k) clearance on 2022-05-17 under 510(k) number K212782. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SternaLock Sternal Closure System?

SternaLock Sternal Closure System is a medical device that received FDA 510(k) clearance on 2022-05-17. The listed applicant is Biomet Microfixation. The 510(k) number is K212782.

When did SternaLock Sternal Closure System receive FDA 510(k) clearance?

SternaLock Sternal Closure System received FDA 510(k) clearance on 2022-05-17, under 510(k) number K212782.

Who is the listed applicant for SternaLock Sternal Closure System?

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

What is the FDA product code for SternaLock Sternal Closure System?

The FDA product code for SternaLock Sternal Closure System is HRS.

其他以 Biomet Microfixation 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。

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相關器械（代碼：HRS）

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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