FDA 510(k)

西羅斯-X系統

K 號：K252322 · 2025-10-22

決定日期2025-10-22

產品代碼OUR

諮詢委員會或

決定相當於

器材摘要

SIros-X System is the device name listed in this FDA 510(k) record. The listed applicant is Genesys Spine. It received FDA 510(k) clearance on 2025-10-22 under 510(k) number K252322. 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 SIros-X System?

SIros-X System is a medical device that received FDA 510(k) clearance on 2025-10-22. The listed applicant is Genesys Spine. The 510(k) number is K252322.

When did SIros-X System receive FDA 510(k) clearance?

SIros-X System received FDA 510(k) clearance on 2025-10-22, under 510(k) number K252322.

Who is the listed applicant for SIros-X System?

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

What is the FDA product code for SIros-X System?

The FDA product code for SIros-X System is OUR.

其他以 Genesys Spine 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。

K242483Genesys脊椎AIS-C II頸椎間融合系統 K233595Genesys脊椎骨盆關節融合系統配導航 K233594Genesys Spine 3DP AIS-C II 頸椎間盤系統 K220096Genesys Spine 3DP 腰椎間盤系統 K191489Genesys脊椎3DP頸椎間盤系統 K182987Genesys Spine 3DP 腰椎間盤系統

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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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