Identity
- Trade Name
- ZENBONE FDA UDI
- Generic Name
- Synthetic bone graft FDA UDI
- Device Name
- ZENBONE is a cotton-like synthetic, resorbable bone void filler. It is composite material consisting of beta-tricalcium phosphate, siloxane-containing vaterite (a form of calcium carbonate), and poly(L-lactide co glycolide). The electrospinning process used in manufacturing ZENBONE results in a cotton-like physical form. Due to its physical form, ZENBONE is flexible and can easily fill defects in appropriate amounts. FDA UDI
- Model / Reference
- 2.0g FDA UDI
- Description
- ZENBONE is a cotton-like synthetic, resorbable bone void filler. It is composite material consisting of beta-tricalcium phosphate, siloxane-containing vaterite (a form of calcium carbonate), and poly(L-lactide co glycolide). The electrospinning process used in manufacturing ZENBONE results in a cotton-like physical form. Due to its physical form, ZENBONE is flexible and can easily fill defects in appropriate amounts. FDA UDI
Identifiers
- Catalog Number
- ORB-0320C-Z FDA UDI
- Primary DI / UDI-DI
- 04573190050613 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
Dimensions & Sizes
- Size
- Total Volume — 20 Milliliter FDA UDI
Category: Synthetic bone graft
Zenbone by Orthorebirth Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Bicera® Resorbable Bone Substitute — WILTROM INC. · Class II
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
- Orthorebirth Co., Ltd.
Sources (1)
- FDA UDI 911b8e86-690b-4eb3-9889-5682ed9197a1 36 fields · synced Jun 8, 2026