Identity
- Trade Name
- MAC-Fuse FDA UDI
- Generic Name
- Synthetic bone graft FDA UDI
- Device Name
- MAC-Fuse, 12cc FDA UDI
- Model / Reference
- 012-MAC FDA UDI
- Description
- MAC-Fuse, 12cc FDA UDI
Identifiers
- Catalog Number
- 012-MAC FDA UDI
- Primary DI / UDI-DI
- 00812593020415 FDA UDI
- 510(k) Number
- K142828 FDA UDI
- FDA Product Code
- MQV FDA UDI
- GMDN Term
- Synthetic bone graft 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Synthetic bone graft
MAC-Fuse by Biogennix, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- InQu — Isto Technologies, Inc. · Class II
Cleared under the same submission
K142828 also covers:
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
- Biogennix, LLC
Sources (1)
- FDA UDI ea6781b2-84ee-4e58-a10b-60106e6cb4e7 36 fields · synced May 30, 2026