FDA 510(k)

X-Fix 線條增強

K 號：K151881 · 2016-03-24

決定日期2016-03-24

產品代碼KTT

諮詢委員會或

決定相當於

器材摘要

X-Fix Line Additions is the device name listed in this FDA 510(k) record. The listed applicant is Vilex IN Tennessee, Inc.. It received FDA 510(k) clearance on 2016-03-24 under 510(k) number K151881. 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 X-Fix Line Additions?

X-Fix Line Additions is a medical device that received FDA 510(k) clearance on 2016-03-24. The listed applicant is Vilex IN Tennessee, Inc.. The 510(k) number is K151881.

When did X-Fix Line Additions receive FDA 510(k) clearance?

X-Fix Line Additions received FDA 510(k) clearance on 2016-03-24, under 510(k) number K151881.

Who is the listed applicant for X-Fix Line Additions?

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

What is the FDA product code for X-Fix Line Additions?

The FDA product code for X-Fix Line Additions is KTT.

其他以 Vilex IN Tennessee, 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。

K191289骨釘線增補 K190543針筒型半植入體 K163487Ultima HA 包覆半針及電纜

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

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。