FDA 510(k)

Genex 骨移植代用品

K 號：K212721 · 2022-02-04

決定日期2022-02-04

產品代碼MQV

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決定相當於

器材摘要

Genex Bone Graft Substitute is the device name listed in this FDA 510(k) record. The listed applicant is Biocomposites, Ltd.. It received FDA 510(k) clearance on 2022-02-04 under 510(k) number K212721. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Genex Bone Graft Substitute?

Genex Bone Graft Substitute is a medical device that received FDA 510(k) clearance on 2022-02-04. The listed applicant is Biocomposites, Ltd.. The 510(k) number is K212721.

When did Genex Bone Graft Substitute receive FDA 510(k) clearance?

Genex Bone Graft Substitute received FDA 510(k) clearance on 2022-02-04, under 510(k) number K212721.

Who is the listed applicant for Genex Bone Graft Substitute?

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

What is the FDA product code for Genex Bone Graft Substitute?

The FDA product code for Genex Bone Graft Substitute is MQV.

其他以 Biocomposites, Ltd. 為申請人之記錄

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相關器械（代碼：MQV）

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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