FDA 510(k)

頸椎支具系統（CSTS）

K 號：K251117 · 2025-04-25

決定日期2025-04-25

產品代碼OVE

諮詢委員會或

決定相當於

器材摘要

Cervical Spine Truss System (CSTS) is the device name listed in this FDA 510(k) record. The listed applicant is 4Web Medical. It received FDA 510(k) clearance on 2025-04-25 under 510(k) number K251117. 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 (CSTS)?

Cervical Spine Truss System (CSTS) is a medical device that received FDA 510(k) clearance on 2025-04-25. The listed applicant is 4Web Medical. The 510(k) number is K251117.

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

Cervical Spine Truss System (CSTS) received FDA 510(k) clearance on 2025-04-25, under 510(k) number K251117.

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

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

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

The FDA product code for Cervical Spine Truss System (CSTS) is OVE.

其他以 4Web Medical 為申請人之記錄

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K252834骨盆釘合系統 (SJTS)

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。

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官方來源

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