FDA 510(k)

2.1 x 255mm 間隙，22mm Stop

K 號：K213072 · 2022-08-23

決定日期2022-08-23

產品代碼HBE

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

2.1 x 255mm Drill, 22mm Stop is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Micofixation. It received FDA 510(k) clearance on 2022-08-23 under 510(k) number K213072. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the 2.1 x 255mm Drill, 22mm Stop?

2.1 x 255mm Drill, 22mm Stop is a medical device that received FDA 510(k) clearance on 2022-08-23. The listed applicant is Biomet Micofixation. The 510(k) number is K213072.

When did 2.1 x 255mm Drill, 22mm Stop receive FDA 510(k) clearance?

2.1 x 255mm Drill, 22mm Stop received FDA 510(k) clearance on 2022-08-23, under 510(k) number K213072.

Who is the listed applicant for 2.1 x 255mm Drill, 22mm Stop?

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 2.1 x 255mm Drill, 22mm Stop?

The FDA product code for 2.1 x 255mm Drill, 22mm Stop is HBE.

其他以 Biomet Micofixation 為申請人之記錄

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相關器械（代碼：HBE）

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