FDA 510(k)

骨盆釘合系統 (SJTS)

K 號：K252834 · 2026-01-28

決定日期2026-01-28

產品代碼OUR

諮詢委員會或

決定相當於

器材摘要

Sacroiliac Joint Truss System (SJTS) is the device name listed in this FDA 510(k) record. The listed applicant is 4Web Medical. It received FDA 510(k) clearance on 2026-01-28 under 510(k) number K252834. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sacroiliac Joint Truss System (SJTS)?

Sacroiliac Joint Truss System (SJTS) is a medical device that received FDA 510(k) clearance on 2026-01-28. The listed applicant is 4Web Medical. The 510(k) number is K252834.

When did Sacroiliac Joint Truss System (SJTS) receive FDA 510(k) clearance?

Sacroiliac Joint Truss System (SJTS) received FDA 510(k) clearance on 2026-01-28, under 510(k) number K252834.

Who is the listed applicant for Sacroiliac Joint Truss System (SJTS)?

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 Sacroiliac Joint Truss System (SJTS)?

The FDA product code for Sacroiliac Joint Truss System (SJTS) is OUR.

其他以 4Web Medical 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。

K251117頸椎支具系統（CSTS）

相關器械（代碼：OUR）

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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