FDA 510(k)

OBS固定位釘，Biokey固定位釘

K 號：K202278 · 2021-01-08

決定日期2021-01-08

產品代碼OAT

諮詢委員會DE

決定相當於

器材摘要

OBS Anchorage Screw, Biokey Anchorage Screw is the device name listed in this FDA 510(k) record. The listed applicant is Bomei Co, Ltd.. It received FDA 510(k) clearance on 2021-01-08 under 510(k) number K202278. The device is classified under product code OAT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OBS Anchorage Screw, Biokey Anchorage Screw?

OBS Anchorage Screw, Biokey Anchorage Screw is a medical device that received FDA 510(k) clearance on 2021-01-08. The listed applicant is Bomei Co, Ltd.. The 510(k) number is K202278.

When did OBS Anchorage Screw, Biokey Anchorage Screw receive FDA 510(k) clearance?

OBS Anchorage Screw, Biokey Anchorage Screw received FDA 510(k) clearance on 2021-01-08, under 510(k) number K202278.

Who is the listed applicant for OBS Anchorage Screw, Biokey Anchorage Screw?

The FDA 510(k) record lists Bomei Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OBS Anchorage Screw, Biokey Anchorage Screw?

The FDA product code for OBS Anchorage Screw, Biokey Anchorage Screw is OAT.

其他以 Bomei Co, Ltd. 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。

K152297OBS 防滑螺釘

相關器械（代碼：OAT）

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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官方來源

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