FDA 510(k)

Atlas Spine Project X 可擴張後腰部椎間系統

K 號：K251969 · 2025-08-15

決定日期2025-08-15

產品代碼MAX

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決定相當於

器材摘要

Atlas Spine Project X Expandable Posterior Lumbar Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Atlas Spine, Inc.. It received FDA 510(k) clearance on 2025-08-15 under 510(k) number K251969. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Atlas Spine Project X Expandable Posterior Lumbar Interbody System?

Atlas Spine Project X Expandable Posterior Lumbar Interbody System is a medical device that received FDA 510(k) clearance on 2025-08-15. The listed applicant is Atlas Spine, Inc.. The 510(k) number is K251969.

When did Atlas Spine Project X Expandable Posterior Lumbar Interbody System receive FDA 510(k) clearance?

Atlas Spine Project X Expandable Posterior Lumbar Interbody System received FDA 510(k) clearance on 2025-08-15, under 510(k) number K251969.

Who is the listed applicant for Atlas Spine Project X Expandable Posterior Lumbar Interbody System?

FDA 510(k) 記錄將 Atlas Spine, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Atlas Spine Project X Expandable Posterior Lumbar Interbody System?

The FDA product code for Atlas Spine Project X Expandable Posterior Lumbar Interbody System is MAX.

其他以 Atlas Spine, Inc. 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。

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相關器械（代碼：MAX）

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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