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FDA 510(k)

Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft

K-Number: K251193 · 2025-06-12

ApplicantMedtronic Sofamor Danek, Inc.
Decision Date2025-06-12
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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