Cleared Traditional

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

K251193 · Medtronic Sofamor Danek, Inc. · Orthopedic
Jun 2025
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K251193 is an FDA 510(k) clearance for the Grafton? DBM; Grafton Plus? DBM Paste; Magnifuse? Bone Graft, a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by Medtronic Sofamor Danek, Inc. (Memphis, US). The FDA issued a Cleared decision on June 12, 2025, 56 days after receiving the submission on April 17, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K251193 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 2025
Decision Date June 12, 2025
Days to Decision 56 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MQV — Filler, Bone Void, Calcium Compound
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3045

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