Identity
- Trade Name
- MAGNIFUSE® Bone Graft FDA UDI
- Generic Name
- Bone matrix implant, human-derived FDA UDI
- Device Name
- DBM 7509010 MAGNIFUSE 10 X 25mm FDA UDI
- Model / Reference
- 7509010 FDA UDI
- Description
- DBM 7509010 MAGNIFUSE 10 X 25mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00613994986474 FDA UDI
- 510(k) Number
- K082615 FDA UDI
- FDA Product Code
- MQV FDA UDI
- GMDN Term
- Bone matrix implant, human-derived FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3045 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
Yes
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Bone matrix implant, human-derived
MAGNIFUSE® Bone Graft by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bone matrix implant, human-derived.
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Cleared under the same submission
K082615 also covers:
- MAGNIFUSE® Bone Graft — MEDTRONIC SOFAMOR DANEK, INC.
- MAGNIFUSE® Bone Graft — MEDTRONIC SOFAMOR DANEK, INC.
- MAGNIFUSE® Bone Graft — MEDTRONIC SOFAMOR DANEK, INC.
- MAGNIFUSE® Bone Graft — MEDTRONIC SOFAMOR DANEK, INC.
- MAGNIFUSE® Bone Graft — MEDTRONIC SOFAMOR DANEK, INC.
- MAGNIFUSE® Bone Graft — MEDTRONIC SOFAMOR DANEK, INC.
- MAGNIFUSE® Bone Graft — MEDTRONIC SOFAMOR DANEK, INC.
- MAGNIFUSE® Bone Graft — MEDTRONIC SOFAMOR DANEK, INC.
- MAGNIFUSE® Bone Graft — MEDTRONIC SOFAMOR DANEK, INC.
- MAGNIFUSE® Bone Graft — MEDTRONIC SOFAMOR DANEK, INC.
- MAGNIFUSE® Bone Graft — MEDTRONIC SOFAMOR DANEK, INC.
- MAGNIFUSE® Bone Graft — MEDTRONIC SOFAMOR DANEK, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medtronic Sofamor Danek, Inc.
Sources (1)
- FDA UDI 595817cc-3273-4379-924b-2e8a178b15d3 37 fields · synced May 30, 2026