FDA 510(k)

Align桡頭系統

K 號：K172688 · 2017-12-22

決定日期2017-12-22

產品代碼KWI

諮詢委員會或

決定相當於

器材摘要

Align Radial Head System is the device name listed in this FDA 510(k) record. The listed applicant is Skeletal Dynamics, LLC. It received FDA 510(k) clearance on 2017-12-22 under 510(k) number K172688. The device is classified under product code KWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Align Radial Head System?

Align Radial Head System is a medical device that received FDA 510(k) clearance on 2017-12-22. The listed applicant is Skeletal Dynamics, LLC. The 510(k) number is K172688.

When did Align Radial Head System receive FDA 510(k) clearance?

Align Radial Head System received FDA 510(k) clearance on 2017-12-22, under 510(k) number K172688.

Who is the listed applicant for Align Radial Head System?

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

What is the FDA product code for Align Radial Head System?

The FDA product code for Align Radial Head System is KWI.

其他以 Skeletal Dynamics, 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。

K182492Geminus Volar 腕骨遠端板系統 K180744Stablyx CMC關節置换植入系統 K171590遠端尺骨板系統

相關器械（代碼：KWI）

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。

K260624Arthrex 放射性頭替換系統Arthrex, Inc.K233592生物多向頭顱植入體BioPoly, LLC K231188ALIGN 極端頭系統Skeletal Dynamics, Inc.K213563DePuy Synthes 放射性頭置換系統DePuy Synthes K212872Avenger 径向頭系統In2bones USA, LLC K192754Avenger 径向頭系統In2bones USA, LLC

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。