FDA 510(k)

單一環椎骨板系統

K 號：K252774 · 2026-04-15

申請人ZheJiang Decans Medical Devices Co., Ltd.

決定日期2026-04-15

產品代碼OVE

諮詢委員會或

決定相當於

器材摘要

Uni-C Cervical Cage System is the device name listed in this FDA 510(k) record. The listed applicant is ZheJiang Decans Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2026-04-15 under 510(k) number K252774. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Uni-C Cervical Cage System?

Uni-C Cervical Cage System is a medical device that received FDA 510(k) clearance on 2026-04-15. The listed applicant is ZheJiang Decans Medical Devices Co., Ltd.. The 510(k) number is K252774.

When did Uni-C Cervical Cage System receive FDA 510(k) clearance?

Uni-C Cervical Cage System received FDA 510(k) clearance on 2026-04-15, under 510(k) number K252774.

Who is the listed applicant for Uni-C Cervical Cage System?

The FDA 510(k) record lists ZheJiang Decans Medical Devices Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Uni-C Cervical Cage System?

The FDA product code for Uni-C Cervical Cage System is OVE.

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相關器械（代碼：OVE）

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