FDA 510(k)

Avanti 骨科尺骨短縮系統

K 號：K211592 · 2021-07-16

決定日期2021-07-16

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

Avanti Orthopaedics Ulnar Shortening System is the device name listed in this FDA 510(k) record. The listed applicant is Avanti Orthopaedics, Inc.. It received FDA 510(k) clearance on 2021-07-16 under 510(k) number K211592. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Avanti Orthopaedics Ulnar Shortening System?

Avanti Orthopaedics Ulnar Shortening System is a medical device that received FDA 510(k) clearance on 2021-07-16. The listed applicant is Avanti Orthopaedics, Inc.. The 510(k) number is K211592.

When did Avanti Orthopaedics Ulnar Shortening System receive FDA 510(k) clearance?

Avanti Orthopaedics Ulnar Shortening System received FDA 510(k) clearance on 2021-07-16, under 510(k) number K211592.

Who is the listed applicant for Avanti Orthopaedics Ulnar Shortening System?

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

What is the FDA product code for Avanti Orthopaedics Ulnar Shortening System?

The FDA product code for Avanti Orthopaedics Ulnar Shortening System is HRS.

其他以 Avanti Orthopaedics, 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。

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相關器械（代碼：HRS）

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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