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FDA 510(k)

Ensemble CMC,尺寸141,Ensemble CMC,尺寸151,Ensemble CMC,尺寸161

K 號:K201072 · 2020-12-02

決定日期2020-12-02
產品代碼KYI
諮詢委員會或
決定相當於

器材摘要

Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 is the device name listed in this FDA 510(k) record. The listed applicant is Ensemble Orthopedics, LLC. It received FDA 510(k) clearance on 2020-12-02 under 510(k) number K201072. The device is classified under product code KYI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161?

Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 is a medical device that received FDA 510(k) clearance on 2020-12-02. The listed applicant is Ensemble Orthopedics, LLC. The 510(k) number is K201072.

When did Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 receive FDA 510(k) clearance?

Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 received FDA 510(k) clearance on 2020-12-02, under 510(k) number K201072.

Who is the listed applicant for Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161?

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

What is the FDA product code for Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161?

The FDA product code for Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 is KYI.

相關臨床試驗

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。

相關器械(代碼:KYI)

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。

官方來源

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