FDA 510(k)

豬骨礦膠複合材

K 號：K202183 · 2021-04-02

決定日期2021-04-02

產品代碼NPM

諮詢委員會DE

決定相當於

器材摘要

Porcine Mineral Collagen Composite is the device name listed in this FDA 510(k) record. The listed applicant is Collagen Matrix, Inc.. It received FDA 510(k) clearance on 2021-04-02 under 510(k) number K202183. 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 Porcine Mineral Collagen Composite?

Porcine Mineral Collagen Composite is a medical device that received FDA 510(k) clearance on 2021-04-02. The listed applicant is Collagen Matrix, Inc.. The 510(k) number is K202183.

When did Porcine Mineral Collagen Composite receive FDA 510(k) clearance?

Porcine Mineral Collagen Composite received FDA 510(k) clearance on 2021-04-02, under 510(k) number K202183.

Who is the listed applicant for Porcine Mineral Collagen Composite?

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

What is the FDA product code for Porcine Mineral Collagen Composite?

The FDA product code for Porcine Mineral Collagen Composite is NPM.

其他以 Collagen Matrix, 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。

K254210REBOHIL（BGM-1、BGM-2、BGM-3、BGM-4、BGM-5）Hyundai Bioland Co., Ltd.K253723BOSSMedpark Co., Ltd.K251786Geistlich Bio-Oss®；Geistlich Bio-Oss Pen®Geistlich Pharma AG K251613瑞士移植XGeistlich Pharma AG K242510Geistlich 生物流®Geistlich Pharma AG K240133異種移植牛骨微粒Collagen Solutions, LLC

官方來源

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