FDA 510(k)

Flex-Z™ 頸椎籠

K 號：K252432 · 2026-03-25

決定日期2026-03-25

產品代碼ODP

諮詢委員會或

決定相當於

器材摘要

Flex-Z™ Cervical Cage is the device name listed in this FDA 510(k) record. The listed applicant is Spinepoint, LLC. It received FDA 510(k) clearance on 2026-03-25 under 510(k) number K252432. 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 Flex-Z™ Cervical Cage?

Flex-Z™ Cervical Cage is a medical device that received FDA 510(k) clearance on 2026-03-25. The listed applicant is Spinepoint, LLC. The 510(k) number is K252432.

When did Flex-Z™ Cervical Cage receive FDA 510(k) clearance?

Flex-Z™ Cervical Cage received FDA 510(k) clearance on 2026-03-25, under 510(k) number K252432.

Who is the listed applicant for Flex-Z™ Cervical Cage?

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

What is the FDA product code for Flex-Z™ Cervical Cage?

The FDA product code for Flex-Z™ Cervical Cage 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