Identity
- Trade Name
- Zavation FDA UDI
- Generic Name
- Bone matrix implant, animal-derived, bioabsorbable FDA UDI
- Device Name
- UNIFUZE 5cc Conform Putty (1 jar dry putty/box), 5cc wet volume FDA UDI
- Model / Reference
- 804-0005 FDA UDI
- Description
- UNIFUZE 5cc Conform Putty (1 jar dry putty/box), 5cc wet volume FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842166128088 FDA UDI
- 510(k) Number
- K052812 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
Single Use
Yes
Implantable
Yes
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Bone matrix implant, animal-derived, bioabsorbable
The Zavation device is a sterile, bioabsorbable bone matrix implant used to fill bone cavities, defects, and fractures. It promotes ingrowth of endogenous bone for skeletal reconstruction or augmentation, making it an effective treatment option for osteoporosis, trauma, surgery, and pathological conditions. With its unique animal-derived bone matrix composition, the Zavation device is designed for single-use implantations.
Similar devices
Also classified as Bone matrix implant, animal-derived, bioabsorbable.
- BoneSync BioActive — COLLAGEN MATRIX, INC. · Class II
- PlatFORM CM Putty — COLLAGEN MATRIX, INC. · Class II
- OssiMend Conformable Putty — COLLAGEN MATRIX, INC. · Class II
- Bio-Reign™ Bioactive — COLLAGEN MATRIX, INC. · Class II
- AccuFuse — COLLAGEN MATRIX, INC. · Class II
- Profiniti Bioactive — COLLAGEN MATRIX, INC. · Class II
- OssiMend Conformable Putty — COLLAGEN MATRIX, INC. · Class II
- Opus™ BA Strip — COLLAGEN MATRIX, INC. · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Zavation
Sources (1)
- FDA UDI 9e3a35d5-a1de-485b-a2c9-e384340bcc26 35 fields · synced Jul 22, 2026