Identity
- Trade Name
- OsteonIII FDA UDI
- Generic Name
- Synthetic bone graft FDA UDI
- Device Name
- Bone grafting material, synthetic FDA UDI
- Model / Reference
- 3G0510200 FDA UDI
- Description
- Bone grafting material, synthetic FDA UDI
Identifiers
- Catalog Number
- 3G0510200 FDA UDI
- Primary DI / UDI-DI
- 08809324768151 FDA UDI
- 510(k) Number
- K153676 FDA UDI
- FDA Product Code
- LYC FDA UDI
- GMDN Term
- Synthetic bone graft FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3930 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Radiation Sterilization FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 2 Milliliter FDA UDI
Category: Synthetic bone graft
OsteonIII by Genoss — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Genoss
Sources (1)
- FDA UDI 9c4ae235-04ea-4664-9ec5-6cd6db4407a8 37 fields · synced Jun 8, 2026