FDA 510(k)

ORIO-3D 金屬網架系統

K 號：K253260 · 2026-04-16

決定日期2026-04-16

產品代碼ODP

諮詢委員會或

決定相當於

器材摘要

ORIO-3D Cage System is the device name listed in this FDA 510(k) record. The listed applicant is SpineCraft. It received FDA 510(k) clearance on 2026-04-16 under 510(k) number K253260. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ORIO-3D Cage System?

ORIO-3D Cage System is a medical device that received FDA 510(k) clearance on 2026-04-16. The listed applicant is SpineCraft. The 510(k) number is K253260.

When did ORIO-3D Cage System receive FDA 510(k) clearance?

ORIO-3D Cage System received FDA 510(k) clearance on 2026-04-16, under 510(k) number K253260.

Who is the listed applicant for ORIO-3D Cage System?

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

What is the FDA product code for ORIO-3D Cage System?

The FDA product code for ORIO-3D Cage System is ODP.

其他以 SpineCraft 為申請人之記錄

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K260015ANTERIS 胸腰椎板系統

相關器械（代碼：ODP）

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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