FDA 510(k)

比奧米特微固定肋骨固定優勢系統

K 號：K203474 · 2021-01-28

決定日期2021-01-28

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

Biomet Microfixation RibFix Advantage System is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Micofixation. It received FDA 510(k) clearance on 2021-01-28 under 510(k) number K203474. 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 Biomet Microfixation RibFix Advantage System?

Biomet Microfixation RibFix Advantage System is a medical device that received FDA 510(k) clearance on 2021-01-28. The listed applicant is Biomet Micofixation. The 510(k) number is K203474.

When did Biomet Microfixation RibFix Advantage System receive FDA 510(k) clearance?

Biomet Microfixation RibFix Advantage System received FDA 510(k) clearance on 2021-01-28, under 510(k) number K203474.

Who is the listed applicant for Biomet Microfixation RibFix Advantage System?

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

What is the FDA product code for Biomet Microfixation RibFix Advantage System?

The FDA product code for Biomet Microfixation RibFix Advantage System is HRS.

其他以 Biomet Micofixation 為申請人之記錄

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K2130722.1 x 255mm 間隙，22mm Stop K212841Pectus Blu 支援條系統

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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