FDA 510(k)

比奧米特微固定 OmniMax MMF 系統

K 號：K202969 · 2021-08-05

決定日期2021-08-05

產品代碼JEY

諮詢委員會DE

決定相當於

器材摘要

Biomet Microfixation OmniMax MMF 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 2021-08-05 under 510(k) number K202969. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Biomet Microfixation OmniMax MMF System?

Biomet Microfixation OmniMax MMF System is a medical device that received FDA 510(k) clearance on 2021-08-05. The listed applicant is Biomet Microfixation. The 510(k) number is K202969.

When did Biomet Microfixation OmniMax MMF System receive FDA 510(k) clearance?

Biomet Microfixation OmniMax MMF System received FDA 510(k) clearance on 2021-08-05, under 510(k) number K202969.

Who is the listed applicant for Biomet Microfixation OmniMax MMF 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 Biomet Microfixation OmniMax MMF System?

The FDA product code for Biomet Microfixation OmniMax MMF System is JEY.

其他以 Biomet Microfixation 為申請人之記錄

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相關器械（代碼：JEY）

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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