FDA 510(k)

ACCUFUSE 頸部系統

K 號：K181471 · 2018-08-29

決定日期2018-08-29

產品代碼ODP

諮詢委員會或

決定相當於

器材摘要

ACCUFUSE Cervical System is the device name listed in this FDA 510(k) record. The listed applicant is Absolute Advantage Medical, LLC. It received FDA 510(k) clearance on 2018-08-29 under 510(k) number K181471. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ACCUFUSE Cervical System?

ACCUFUSE Cervical System is a medical device that received FDA 510(k) clearance on 2018-08-29. The listed applicant is Absolute Advantage Medical, LLC. The 510(k) number is K181471.

When did ACCUFUSE Cervical System receive FDA 510(k) clearance?

ACCUFUSE Cervical System received FDA 510(k) clearance on 2018-08-29, under 510(k) number K181471.

Who is the listed applicant for ACCUFUSE Cervical System?

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

What is the FDA product code for ACCUFUSE Cervical System?

The FDA product code for ACCUFUSE Cervical System is ODP.

相關器械（代碼：ODP）

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。

K262595VariLift-C 頸椎間融合系統Wenzel Spine, Inc.K262489BluEX 頸椎擴張籠系統L&K BIOMED Co., Ltd.K2530413D籠架頸椎Fims Co., Ltd.K262061Tritanium® C 頸椎前方金層；Tritanium® PL 金層；Tritanium® TL 弯曲後腰金層；Aero® -C 頸椎金層系統；AVS® Anchor-C 頸椎金層系統；AVS® TL PEEK 间隔器；AVS® PL PEEK 间隔器；AVS® Navigator PEEK 间隔器；AVS® AS PEEK 间隔器；Monterey™ AL 間體系統；Aleutian IBF 系統；Cascadia 間體系統；Chesapeake 稳定系統；Sahara 稳定系統；SANTORINI™ 去骨金層系統；MOJAVE 間體系統；VLIFT VERTEBRAL BODY REPLACEMStryker Spine K254130C.A. 医療間體融合系統C.A. Medical, LLC K260840BluEX 頸椎擴張籠系統L&K BIOMED Co., Ltd.

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。

器材摘要

常見問題

相關臨床試驗

相關器械（代碼：ODP）

官方來源