FDA 510(k)

Grafton™ DBM；Grafton Plus™ DBM膠；Magnifuse™骨移植

K 號：K251193 · 2025-06-12

決定日期2025-06-12

產品代碼MQV

諮詢委員會或

決定相當於

器材摘要

Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek, Inc.. It received FDA 510(k) clearance on 2025-06-12 under 510(k) number K251193. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft?

Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft is a medical device that received FDA 510(k) clearance on 2025-06-12. The listed applicant is Medtronic Sofamor Danek, Inc.. The 510(k) number is K251193.

When did Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft receive FDA 510(k) clearance?

Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft received FDA 510(k) clearance on 2025-06-12, under 510(k) number K251193.

Who is the listed applicant for Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft?

The FDA 510(k) record lists Medtronic Sofamor Danek, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft?

The FDA product code for Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft is MQV.

其他以 Medtronic Sofamor Danek, Inc. 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。

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相關器械（代碼：MQV）

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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