FDA 510(k)

生物多孔聚乙烯植入物

K 號：K161446 · 2016-09-27

決定日期2016-09-27

產品代碼GWO

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Biopor Porous Polyethylene Implants is the device name listed in this FDA 510(k) record. The listed applicant is Ceremed , Inc.. It received FDA 510(k) clearance on 2016-09-27 under 510(k) number K161446. The device is classified under product code GWO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Biopor Porous Polyethylene Implants?

Biopor Porous Polyethylene Implants is a medical device that received FDA 510(k) clearance on 2016-09-27. The listed applicant is Ceremed , Inc.. The 510(k) number is K161446.

When did Biopor Porous Polyethylene Implants receive FDA 510(k) clearance?

Biopor Porous Polyethylene Implants received FDA 510(k) clearance on 2016-09-27, under 510(k) number K161446.

Who is the listed applicant for Biopor Porous Polyethylene Implants?

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

What is the FDA product code for Biopor Porous Polyethylene Implants?

The FDA product code for Biopor Porous Polyethylene Implants is GWO.

其他以 Ceremed , Inc. 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。

K160988Biopor，AOC多孔聚乙烯，Cerepor

相關器械（代碼：GWO）

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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