FDA 510(k)

Galaxy UNYCO 系統

K 號：K153233 · 2016-01-06

決定日期2016-01-06

產品代碼KTT

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決定相當於

器材摘要

Galaxy UNYCO System is the device name listed in this FDA 510(k) record. The listed applicant is Orthofix Srl. It received FDA 510(k) clearance on 2016-01-06 under 510(k) number K153233. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Galaxy UNYCO System?

Galaxy UNYCO System is a medical device that received FDA 510(k) clearance on 2016-01-06. The listed applicant is Orthofix Srl. The 510(k) number is K153233.

When did Galaxy UNYCO System receive FDA 510(k) clearance?

Galaxy UNYCO System received FDA 510(k) clearance on 2016-01-06, under 510(k) number K153233.

Who is the listed applicant for Galaxy UNYCO System?

The FDA 510(k) record lists Orthofix Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Galaxy UNYCO System?

The FDA product code for Galaxy UNYCO System is KTT.

其他以 Orthofix Srl 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。

K260146FITBONE® 転移與延長系統 K253991Fitbone™ 髋臼，FITBONE® 运輸及延長系統，FITBONE® TAA K250112Fitbone™ 髋臼突盤 K242270正骨科Next平台系統 K242861TrueLok Elevate K233867Fitbone 髋臼突盤

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相關器械（代碼：KTT）

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。

K254087MAXFRAME AUTOSTRUT™ 內建藍牙多軸校正系統Synthes (USA) Products, LLC K260900DYNEX® 外固定系統Vilex, LLC K260112QuikFix 外固定器：膝蓋跨包Stabiliz Orthopaedics, Inc.K253291優越系統Blue Ocean Global K253613猴環外環固定系統Paragon 28, Inc.K253202霍夫曼LRF系統Stryker GmbH

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