FDA 510(k)

UniSpace® TPLIF 金層

K 號：K252351 · 2025-10-28

決定日期2025-10-28

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

UniSpace® TPLIF Cage is the device name listed in this FDA 510(k) record. The listed applicant is Cg Medtech Co., Ltd.. It received FDA 510(k) clearance on 2025-10-28 under 510(k) number K252351. 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 UniSpace® TPLIF Cage?

UniSpace® TPLIF Cage is a medical device that received FDA 510(k) clearance on 2025-10-28. The listed applicant is Cg Medtech Co., Ltd.. The 510(k) number is K252351.

When did UniSpace® TPLIF Cage receive FDA 510(k) clearance?

UniSpace® TPLIF Cage received FDA 510(k) clearance on 2025-10-28, under 510(k) number K252351.

Who is the listed applicant for UniSpace® TPLIF Cage?

The FDA 510(k) record lists Cg Medtech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UniSpace® TPLIF Cage?

The FDA product code for UniSpace® TPLIF Cage is MAX.

其他以 Cg Medtech Co., Ltd. 為申請人之記錄

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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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