FDA 510(k)

Sacroiliac Joint Truss System (SJTS)

K番号: K252834 · 2026-01-28

決定日2026-01-28

製品コードOUR

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OR [翻訳] OR 注：原文が具体的な内容を含んでいないため、翻訳は単なる「OR」のままです。

決定Substantially Equivalent

医療機器の概要

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.

よくある質問

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.

申請者として4Web Medicalを記載するその他の記録

K251117頸椎骨継手装置（Cervical Spine Truss System、CSTS）

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