FDA 510(k)

3DMatrix DynaFlex (DynaFlex)

K 號：K243302 · 2025-05-21

決定日期2025-05-21

產品代碼OXF

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

3DMatrix DynaFlex (DynaFlex) is the device name listed in this FDA 510(k) record. The listed applicant is Printbio, Inc.. It received FDA 510(k) clearance on 2025-05-21 under 510(k) number K243302. The device is classified under product code OXF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the 3DMatrix DynaFlex (DynaFlex)?

3DMatrix DynaFlex (DynaFlex) is a medical device that received FDA 510(k) clearance on 2025-05-21. The listed applicant is Printbio, Inc.. The 510(k) number is K243302.

When did 3DMatrix DynaFlex (DynaFlex) receive FDA 510(k) clearance?

3DMatrix DynaFlex (DynaFlex) received FDA 510(k) clearance on 2025-05-21, under 510(k) number K243302.

Who is the listed applicant for 3DMatrix DynaFlex (DynaFlex)?

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

What is the FDA product code for 3DMatrix DynaFlex (DynaFlex)?

The FDA product code for 3DMatrix DynaFlex (DynaFlex) is OXF.

其他以 Printbio, Inc. 為申請人之記錄

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K2326023DMatrix外科網格

相關器械（代碼：OXF）

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。

K251224Restrata軟組織加固（STR）Acera Surgical, Inc.K2326023DMatrix外科網格Printbio, Inc.K222919GORE® ENFORM 生物材質W. L. Gore and Associates, Inc.K173333GORE ENFORM 生物材料W. L. Gore & Associates, Inc.K172545SERI 曲面Sofregen Medical, Inc.K163217GORE BIO-A 組織強化劑W. L. Gore & Associates, Inc.

官方來源

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