FDA 510(k)

CoLumbo C脊椎

K 號：K254015 · 2026-04-01

決定日期2026-04-01

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

CoLumbo C-Spine is the device name listed in this FDA 510(k) record. The listed applicant is Smart Soft Healthcare AD. It received FDA 510(k) clearance on 2026-04-01 under 510(k) number K254015. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CoLumbo C-Spine?

CoLumbo C-Spine is a medical device that received FDA 510(k) clearance on 2026-04-01. The listed applicant is Smart Soft Healthcare AD. The 510(k) number is K254015.

When did CoLumbo C-Spine receive FDA 510(k) clearance?

CoLumbo C-Spine received FDA 510(k) clearance on 2026-04-01, under 510(k) number K254015.

Who is the listed applicant for CoLumbo C-Spine?

The FDA 510(k) record lists Smart Soft Healthcare AD as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CoLumbo C-Spine?

The FDA product code for CoLumbo C-Spine is QIH.

其他以 Smart Soft Healthcare AD 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。

K250367CoLumboX K220497CoLumbo

相關器械（代碼：QIH）

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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