FDA 510(k)

科羅拉多治療學異種移植植入體

K 號：K172937 · 2017-10-25

決定日期2017-10-25

產品代碼FTM

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

Colorado Therapeutics Xenograft Implant is the device name listed in this FDA 510(k) record. The listed applicant is Colorado Therapeutics, LLC. It received FDA 510(k) clearance on 2017-10-25 under 510(k) number K172937. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Colorado Therapeutics Xenograft Implant?

Colorado Therapeutics Xenograft Implant is a medical device that received FDA 510(k) clearance on 2017-10-25. The listed applicant is Colorado Therapeutics, LLC. The 510(k) number is K172937.

When did Colorado Therapeutics Xenograft Implant receive FDA 510(k) clearance?

Colorado Therapeutics Xenograft Implant received FDA 510(k) clearance on 2017-10-25, under 510(k) number K172937.

Who is the listed applicant for Colorado Therapeutics Xenograft Implant?

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

What is the FDA product code for Colorado Therapeutics Xenograft Implant?

The FDA product code for Colorado Therapeutics Xenograft Implant is FTM.

其他以 Colorado Therapeutics, LLC 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。

K160181科羅拉多治療學異種移植植入體

相關器械（代碼：FTM）

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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