K251193
- 510(k) number
- K251193
- Device name
- Grafton DBM; Grafton Plus DBM Paste; Magnifuse Bone Graft
- Applicant
- Medtronic Sofamor Danek, Inc. TN · US
- Product code
- MQV — Filler, Bone Void, Calcium Compound
- Decision date
- 2025-06-12
- Date received
- 2025-04-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K251193.pdf
Official FDA record: K251193
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.