FDA 510(k)

客製化外型植入體

K 號：K191130 · 2019-08-23

決定日期2019-08-23

產品代碼FWP

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

Customized Contour Implant is the device name listed in this FDA 510(k) record. The listed applicant is Implantech Associates, Inc.. It received FDA 510(k) clearance on 2019-08-23 under 510(k) number K191130. The device is classified under product code FWP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Customized Contour Implant?

Customized Contour Implant is a medical device that received FDA 510(k) clearance on 2019-08-23. The listed applicant is Implantech Associates, Inc.. The 510(k) number is K191130.

When did Customized Contour Implant receive FDA 510(k) clearance?

Customized Contour Implant received FDA 510(k) clearance on 2019-08-23, under 510(k) number K191130.

Who is the listed applicant for Customized Contour Implant?

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

What is the FDA product code for Customized Contour Implant?

The FDA product code for Customized Contour Implant is FWP.

其他以 Implantech Associates, 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。

K200610客製化外型植入體 K172389ePTFE塗層耳植入體

相關器械（代碼：FWP）

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。

K254233醫用設備規範文本翻譯： MEDPOR客製化植入套件Stryker Leibinger GmbH & Co KG K232593FITme 適用式矽膠植入體Keosan Trading Co.K200610客製化外型植入體Implantech Associates, Inc.K191916Stryker CMF MEDPOR 優先級客製化植入器材套件Stryker Leibinger GmbH & Co KG K153508Stryker CMF 医用設備規範文本 Stryker CMF 匯編式植體Stryker K152463SU-POR 頭部專屬植入物，SU-POR 面部專屬植入物Poriferous, LLC

官方來源

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