FDA 510(k)

KHEIRON® Spinal Fixation System, including patient specific K-ROD

K 號：K262828 · 2026-09-04

申請人S.M.A.I.O

決定日期2026-09-04

產品代碼NKB

諮詢委員會OR

決定Substantially Equivalent

器材摘要

KHEIRON® Spinal Fixation System, including patient specific K-ROD is the device name listed in this FDA 510(k) record. The listed applicant is S.M.A.I.O. It received FDA 510(k) clearance on 2026-09-04 under 510(k) number K262828. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the KHEIRON® Spinal Fixation System, including patient specific K-ROD?

KHEIRON® Spinal Fixation System, including patient specific K-ROD is a medical device that received FDA 510(k) clearance on 2026-09-04. The listed applicant is S.M.A.I.O. The 510(k) number is K262828.

When did KHEIRON® Spinal Fixation System, including patient specific K-ROD receive FDA 510(k) clearance?

KHEIRON® Spinal Fixation System, including patient specific K-ROD received FDA 510(k) clearance on 2026-09-04, under 510(k) number K262828.

Who is the listed applicant for KHEIRON® Spinal Fixation System, including patient specific K-ROD?

The FDA 510(k) record lists S.M.A.I.O as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KHEIRON® Spinal Fixation System, including patient specific K-ROD?

The FDA product code for KHEIRON® Spinal Fixation System, including patient specific K-ROD is NKB.

其他以 S.M.A.I.O 為申請人之記錄

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相關器械（代碼：NKB）

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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