FDA 510(k)

頸椎骨盆系統（CSTS）間體融合裝置

K 號：K221266 · 2023-01-05

決定日期2023-01-05

產品代碼ODP

諮詢委員會或

決定相當於

器材摘要

Cervical Spine Truss System (CSTS) Interbody Fusion Device is the device name listed in this FDA 510(k) record. The listed applicant is 4Web Medical, Inc.. It received FDA 510(k) clearance on 2023-01-05 under 510(k) number K221266. 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 Cervical Spine Truss System (CSTS) Interbody Fusion Device?

Cervical Spine Truss System (CSTS) Interbody Fusion Device is a medical device that received FDA 510(k) clearance on 2023-01-05. The listed applicant is 4Web Medical, Inc.. The 510(k) number is K221266.

When did Cervical Spine Truss System (CSTS) Interbody Fusion Device receive FDA 510(k) clearance?

Cervical Spine Truss System (CSTS) Interbody Fusion Device received FDA 510(k) clearance on 2023-01-05, under 510(k) number K221266.

Who is the listed applicant for Cervical Spine Truss System (CSTS) Interbody Fusion Device?

The FDA 510(k) record lists 4Web Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cervical Spine Truss System (CSTS) Interbody Fusion Device?

The FDA product code for Cervical Spine Truss System (CSTS) Interbody Fusion Device is ODP.

其他以 4Web Medical, 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。

K253200頸椎支撐系統 - 独立型（CSTS-SA）K240388骨切架系統（OTS）K233966前脊柱支架系統-獨立型（ASTS-SA）K230088踝關節支具系統 (ATS)K231739頸椎支具系統（CSTS）K223362頸椎骨盆系統 - 独立型（CSTS-SA）椎間融合設備

查看所有 11 項裝置 →

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。