FDA 510(k)

胸骨支撐條系統

K 號：K213712 · 2022-03-11

決定日期2022-03-11

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

Pectus Support Bar 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 2022-03-11 under 510(k) number K213712. 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 Pectus Support Bar System?

Pectus Support Bar System is a medical device that received FDA 510(k) clearance on 2022-03-11. The listed applicant is Biomet Microfixation. The 510(k) number is K213712.

When did Pectus Support Bar System receive FDA 510(k) clearance?

Pectus Support Bar System received FDA 510(k) clearance on 2022-03-11, under 510(k) number K213712.

Who is the listed applicant for Pectus Support Bar 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 Pectus Support Bar System?

The FDA product code for Pectus Support Bar 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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