FDA 510(k)

FacetBRIDGE® 系統

K 號：K161798 · 2016-08-04

決定日期2016-08-04

產品代碼MRW

決定相當於

器材摘要

FacetBRIDGE® System is the device name listed in this FDA 510(k) record. The listed applicant is Ldr Spine USA, Inc.. It received FDA 510(k) clearance on 2016-08-04 under 510(k) number K161798. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

常見問題

What is the FacetBRIDGE® System?

FacetBRIDGE® System is a medical device that received FDA 510(k) clearance on 2016-08-04. The listed applicant is Ldr Spine USA, Inc.. The 510(k) number is K161798.

When did FacetBRIDGE® System receive FDA 510(k) clearance?

FacetBRIDGE® System received FDA 510(k) clearance on 2016-08-04, under 510(k) number K161798.

Who is the listed applicant for FacetBRIDGE® System?

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

What is the FDA product code for FacetBRIDGE® System?

The FDA product code for FacetBRIDGE® System is MRW.

其他以 Ldr Spine USA, 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。

K162133VerteFIT脊椎切除籠架系統 K161173Avenue® T TLIF 籠

相關器械（代碼：MRW）

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。

K262618Arthrex 腰椎壓縮 FT 螺釘Arthrex, Inc.K261209離子-L (注意：原文中 "device_name" 和 "medical-device regulatory text" 沒有提供完整的內容，因此只能根據 "Ion-L" 進行翻譯。如果需要完整的翻譯，請提供完整的文本。)SurGenTec, LLC K253676CORUS™ 頸後穩定系統 3D (CORUS™ PCSS 3D)Providence Medical Technology, Inc.K253432DiversiVy™ 面板螺釘系統Vy Spine, LLC K251714離子-CSurGenTec, LLC K250679FFX 面板固定系統Sc Medica

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。