FDA 510(k)

定位器 F-Tx 附著系統

K 號：K151789 · 2016-03-04

決定日期2016-03-04

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

LOCATOR F-Tx Attachment System is the device name listed in this FDA 510(k) record. The listed applicant is Zest Anchors, LLC. It received FDA 510(k) clearance on 2016-03-04 under 510(k) number K151789. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LOCATOR F-Tx Attachment System?

LOCATOR F-Tx Attachment System is a medical device that received FDA 510(k) clearance on 2016-03-04. The listed applicant is Zest Anchors, LLC. The 510(k) number is K151789.

When did LOCATOR F-Tx Attachment System receive FDA 510(k) clearance?

LOCATOR F-Tx Attachment System received FDA 510(k) clearance on 2016-03-04, under 510(k) number K151789.

Who is the listed applicant for LOCATOR F-Tx Attachment System?

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

What is the FDA product code for LOCATOR F-Tx Attachment System?

The FDA product code for LOCATOR F-Tx Attachment System is NHA.

其他以 Zest Anchors, 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。

K260555LOCATOR® 角度基座 K252944LOCATOR® 角度基座 K250721LOCATOR® 角度基座 K243272定位器斜支承 K233587定位器斜支承（各種）K220252高保留附著系統

查看所有 9 項裝置 →

相關器械（代碼：NHA）

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。

K262207固定式加長基座Unidental Co., Ltd.K260940貝拉特克條ZimVie US Corp, LLC K253999通用基座 ASC 接合；通用基座 ASC 非接合；通用基座 MUA ASC；臨時基座接合和非接合；恢復基座極锥連接；Omnigrip臨床螺釘鈦金；Omnigrip假牙螺釘Nobel Biocare AB K261147Neodent植牙系統 - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLC K260061生物地平線 CEREC 兼容 Ti-BasesBioHorizons Implant Systems, Inc.

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。