FDA 510(k)

KOSMO 髋關節柄

K 號：K202768 · 2021-04-01

決定日期2021-04-01

產品代碼LZO

諮詢委員會或

決定相當於

器材摘要

KOSMO Femoral Stem is the device name listed in this FDA 510(k) record. The listed applicant is B-One Ortho, Corp.. It received FDA 510(k) clearance on 2021-04-01 under 510(k) number K202768. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the KOSMO Femoral Stem?

KOSMO Femoral Stem is a medical device that received FDA 510(k) clearance on 2021-04-01. The listed applicant is B-One Ortho, Corp.. The 510(k) number is K202768.

When did KOSMO Femoral Stem receive FDA 510(k) clearance?

KOSMO Femoral Stem received FDA 510(k) clearance on 2021-04-01, under 510(k) number K202768.

Who is the listed applicant for KOSMO Femoral Stem?

FDA 510(k) 記錄將 B-One Ortho, Corp. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for KOSMO Femoral Stem?

The FDA product code for KOSMO Femoral Stem is LZO.

其他以 B-One Ortho, Corp. 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：LZO）

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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