FDA 510(k)

HEDRON™ 頸椎間隔器（HEDRON C-MIS™ 間隔器）

K 號：K253876 · 2025-12-22

決定日期2025-12-22

產品代碼OVE

諮詢委員會或

決定相當於

器材摘要

HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) is the device name listed in this FDA 510(k) record. The listed applicant is Globus Medical, Inc.. It received FDA 510(k) clearance on 2025-12-22 under 510(k) number K253876. 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 HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)?

HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) is a medical device that received FDA 510(k) clearance on 2025-12-22. The listed applicant is Globus Medical, Inc.. The 510(k) number is K253876.

When did HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) receive FDA 510(k) clearance?

HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) received FDA 510(k) clearance on 2025-12-22, under 510(k) number K253876.

Who is the listed applicant for HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)?

FDA 510(k) 記錄將 Globus Medical, 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 HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)?

The FDA product code for HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) is OVE.

其他以 Globus Medical, Inc. 為申請人之記錄

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相關器械（代碼：OVE）

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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