FDA 510(k)

移植骨代用品

K 號：K191737 · 2020-02-14

決定日期2020-02-14

產品代碼NPM

諮詢委員會DE

決定相當於

器材摘要

The Graft Bone Substitute is the device name listed in this FDA 510(k) record. The listed applicant is Purgo Biologics, Inc.. It received FDA 510(k) clearance on 2020-02-14 under 510(k) number K191737. The device is classified under product code NPM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the The Graft Bone Substitute?

The Graft Bone Substitute is a medical device that received FDA 510(k) clearance on 2020-02-14. The listed applicant is Purgo Biologics, Inc.. The 510(k) number is K191737.

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

The Graft Bone Substitute received FDA 510(k) clearance on 2020-02-14, under 510(k) number K191737.

Who is the listed applicant for The Graft Bone Substitute?

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

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

The FDA product code for The Graft Bone Substitute is NPM.

其他以 Purgo Biologics, Inc. 為申請人之記錄

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相關器械（代碼：NPM）

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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