FDA 510(k)

A-CIFT SoloFuse

K 號：K172484 · 2018-05-08

決定日期2018-05-08

產品代碼OVE

諮詢委員會或

決定相當於

器材摘要

A-CIFT SoloFuse is the device name listed in this FDA 510(k) record. The listed applicant is Spinefrontier, Inc.. It received FDA 510(k) clearance on 2018-05-08 under 510(k) number K172484. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the A-CIFT SoloFuse?

A-CIFT SoloFuse is a medical device that received FDA 510(k) clearance on 2018-05-08. The listed applicant is Spinefrontier, Inc.. The 510(k) number is K172484.

When did A-CIFT SoloFuse receive FDA 510(k) clearance?

A-CIFT SoloFuse received FDA 510(k) clearance on 2018-05-08, under 510(k) number K172484.

Who is the listed applicant for A-CIFT SoloFuse?

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

What is the FDA product code for A-CIFT SoloFuse?

The FDA product code for A-CIFT SoloFuse is OVE.

其他以 Spinefrontier, 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。

K193106SpineFrontier 腰椎間融合器系統

相關器械（代碼：OVE）

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。

K263049SABER-C 系統Elevation Spine K261882Pisces-SC 独立颈椎間盤系統Osseus Fusions Systems, LLC K261451ZSAlign脊椎間盤系統ZSFab, Inc.K262094E3D™-C 間體系統Evolution Spine K261279DeltaNEC 間隙系統Nexus Spine K252982CONDUIT™ 零-P™ 維護隔離系統Avalign Technologies, 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。