FDA 510(k)

瓷質骨空洞填充物

K 號：K201535 · 2020-10-16

決定日期2020-10-16

產品代碼MQV

諮詢委員會或

決定相當於

器材摘要

Cerament Bone Void Filler is the device name listed in this FDA 510(k) record. The listed applicant is Bonesupport AB. It received FDA 510(k) clearance on 2020-10-16 under 510(k) number K201535. 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 Cerament Bone Void Filler?

Cerament Bone Void Filler is a medical device that received FDA 510(k) clearance on 2020-10-16. The listed applicant is Bonesupport AB. The 510(k) number is K201535.

When did Cerament Bone Void Filler receive FDA 510(k) clearance?

Cerament Bone Void Filler received FDA 510(k) clearance on 2020-10-16, under 510(k) number K201535.

Who is the listed applicant for Cerament Bone Void Filler?

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

What is the FDA product code for Cerament Bone Void Filler?

The FDA product code for Cerament Bone Void Filler is MQV.

其他以 Bonesupport AB 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。

K234008CERAMENT G K240459瓷質骨空洞填充物

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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官方來源

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