FDA 510(k)

頸椎支撐系統 - 独立型（CSTS-SA）

K 號：K253200 · 2025-12-11

決定日期2025-12-11

產品代碼OVE

諮詢委員會或

決定相當於

器材摘要

Cervical Spine Truss System - Stand Alone (CSTS-SA) 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 2025-12-11 under 510(k) number K253200. 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 Cervical Spine Truss System - Stand Alone (CSTS-SA)?

Cervical Spine Truss System - Stand Alone (CSTS-SA) is a medical device that received FDA 510(k) clearance on 2025-12-11. The listed applicant is 4Web Medical, Inc.. The 510(k) number is K253200.

When did Cervical Spine Truss System - Stand Alone (CSTS-SA) receive FDA 510(k) clearance?

Cervical Spine Truss System - Stand Alone (CSTS-SA) received FDA 510(k) clearance on 2025-12-11, under 510(k) number K253200.

Who is the listed applicant for Cervical Spine Truss System - Stand Alone (CSTS-SA)?

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 - Stand Alone (CSTS-SA)?

The FDA product code for Cervical Spine Truss System - Stand Alone (CSTS-SA) is OVE.

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。

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 K221266頸椎骨盆系統（CSTS）間體融合裝置

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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

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