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 a medical device manufactured by Medtronic Sofamor Danek, Inc.. It received FDA 510(k) clearance on 2025-06-12 under approval 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. It is manufactured by Medtronic Sofamor Danek, Inc.. The 510(k) number is K251193.
When was Grafton DBM; Grafton Plus DBM Paste; Magnifuse Bone Graft approved by the FDA?
Grafton DBM; Grafton Plus DBM Paste; Magnifuse Bone Graft received FDA 510(k) clearance on 2025-06-12, under approval number K251193.
What company makes Grafton DBM; Grafton Plus DBM Paste; Magnifuse Bone Graft?
Grafton DBM; Grafton Plus DBM Paste; Magnifuse Bone Graft is manufactured by Medtronic Sofamor Danek, Inc..
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.
Other Devices by Medtronic Sofamor Danek, Inc.
Related Devices (Code: MQV)
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.