FDA 510(k)

頸椎脊柱支撐系統（Cervical Spinal Truss System, CSTS）內固定融合裝置

K 號：K173159 · 2018-01-08

決定日期2018-01-08

產品代碼ODP

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決定相當於

器材摘要

Cervical Spinal Truss System (CSTS) Interbody Fusion Device is the device name listed in this FDA 510(k) record. The listed applicant is 4Web, Inc.. It received FDA 510(k) clearance on 2018-01-08 under 510(k) number K173159. 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 Spinal Truss System (CSTS) Interbody Fusion Device?

Cervical Spinal Truss System (CSTS) Interbody Fusion Device is a medical device that received FDA 510(k) clearance on 2018-01-08. The listed applicant is 4Web, Inc.. The 510(k) number is K173159.

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

Cervical Spinal Truss System (CSTS) Interbody Fusion Device received FDA 510(k) clearance on 2018-01-08, under 510(k) number K173159.

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

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

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

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

其他以 4Web, 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。

K253201腰椎脊柱支架系統 - 鋼板解決方案（LSTS-PS）K203065腰椎脊柱支架系統板金解決方案（LSTS-PS）K200002前脊柱支架系統 – 独立型（ASTS-SA）椎間融合設備 K190870頸椎脊柱支撐系統-獨立型（CSTS-SA）K190926鍵節固定系統（HTS）K172294骨切架系統（OTS）

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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.

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