FDA 510(k)

XeliteMed VertehighFix 高濃度脊椎骨水泥系統

K 號：K243537 · 2025-04-11

決定日期2025-04-11

產品代碼NDN

諮詢委員會或

決定相當於

器材摘要

XeliteMed VertehighFix High Viscosity Spinal Bone Cement System 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 2025-04-11 under 510(k) number K243537. 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 VertehighFix High Viscosity Spinal Bone Cement System?

XeliteMed VertehighFix High Viscosity Spinal Bone Cement System is a medical device that received FDA 510(k) clearance on 2025-04-11. The listed applicant is Xelite Biomed , Ltd.. The 510(k) number is K243537.

When did XeliteMed VertehighFix High Viscosity Spinal Bone Cement System receive FDA 510(k) clearance?

XeliteMed VertehighFix High Viscosity Spinal Bone Cement System received FDA 510(k) clearance on 2025-04-11, under 510(k) number K243537.

Who is the listed applicant for XeliteMed VertehighFix High Viscosity Spinal Bone Cement System?

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 VertehighFix High Viscosity Spinal Bone Cement System?

The FDA product code for XeliteMed VertehighFix High Viscosity Spinal Bone Cement System 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。

K251896XeliteMed 超級固定脊椎骨水泥 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。

K251896XeliteMed 超級固定脊椎骨水泥Xelite Biomed , Ltd.K250637VCFix脊椎系統Amber Implants 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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