Identity
- Trade Name
- MASTERGRAFT®Putty FDA UDI
- Generic Name
- Bone matrix implant, animal-derived, bioabsorbable FDA UDI
- Device Name
- BIOLOGICS 7600703 MSTRGRFT PUTY 3 CC KIT FDA UDI
- Model / Reference
- 7600703 FDA UDI
- Description
- BIOLOGICS 7600703 MSTRGRFT PUTY 3 CC KIT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169486430 FDA UDI
- FDA Product Code
- MQV FDA UDI
- GMDN Term
- Bone matrix implant, animal-derived, bioabsorbable 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
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bone matrix implant, animal-derived, bioabsorbable
MASTERGRAFT®Putty by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone matrix implant, animal-derived, bioabsorbable.
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- Opus™ BA Strip — COLLAGEN MATRIX, INC. · Class II
Cleared under the same submission
K051386 also covers:
K140374 also covers:
- MASTERGRAFT®Putty — MEDTRONIC SOFAMOR DANEK, INC.
- MASTERGRAFT®Putty — MEDTRONIC SOFAMOR DANEK, INC.
- MASTERGRAFT®Putty — MEDTRONIC SOFAMOR DANEK, INC.
- MASTERGRAFT®Putty — MEDTRONIC SOFAMOR DANEK, INC.
- MASTERGRAFT®Putty — MEDTRONIC SOFAMOR DANEK, INC.
- MASTERGRAFT®Putty — MEDTRONIC SOFAMOR DANEK, INC.
- MASTERGRAFT®Putty — MEDTRONIC SOFAMOR DANEK, INC.
- MASTERGRAFT®Putty — MEDTRONIC SOFAMOR DANEK, INC.
- MASTERGRAFT®Putty — 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 8bc5384c-3c03-4b9a-9ff0-186931406b84 36 fields · synced May 30, 2026