FDA 510(k)

XeliteMed 超級固定脊椎骨水泥

K 號：K251896 · 2026-01-28

決定日期2026-01-28

產品代碼NDN

諮詢委員會或

決定相當於

器材摘要

XeliteMed SuperM-Fix Spinal Bone Cement is the device name listed in this FDA 510(k) record. The listed applicant is Xelite Biomed , Ltd.. It received FDA 510(k) clearance on 2026-01-28 under 510(k) number K251896. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the XeliteMed SuperM-Fix Spinal Bone Cement?

XeliteMed SuperM-Fix Spinal Bone Cement is a medical device that received FDA 510(k) clearance on 2026-01-28. The listed applicant is Xelite Biomed , Ltd.. The 510(k) number is K251896.

When did XeliteMed SuperM-Fix Spinal Bone Cement receive FDA 510(k) clearance?

XeliteMed SuperM-Fix Spinal Bone Cement received FDA 510(k) clearance on 2026-01-28, under 510(k) number K251896.

Who is the listed applicant for XeliteMed SuperM-Fix Spinal Bone Cement?

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

What is the FDA product code for XeliteMed SuperM-Fix Spinal Bone Cement?

The FDA product code for XeliteMed SuperM-Fix Spinal Bone Cement is NDN.

其他以 Xelite Biomed , Ltd. 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。

K243537XeliteMed VertehighFix 高濃度脊椎骨水泥系統 K241775XeliteMed VertehighFix 高濃度脊椎骨水泥

相關器械（代碼：NDN）

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。

K250637VCFix脊椎系統Amber Implants K243537XeliteMed VertehighFix 高濃度脊椎骨水泥系統Xelite Biomed , Ltd.K241775XeliteMed VertehighFix 高濃度脊椎骨水泥Xelite Biomed , Ltd.K232842氣球充氣系統Ningbo Hicren Biotechnology Co., Ltd.K240084V-STRUT®脊椎植入體Hyprevention K231340雷諾瓦脊椎氣囊導管Biopsybell S.R.L.

官方來源

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