Identity
- Trade Name
- TRIOSITE FDA UDI
- Generic Name
- Bone matrix implant, synthetic, non-antimicrobial FDA UDI
- Device Name
- Synthetic Bone Resorbable Graft Stick 5x5x20mm FDA UDI
- Model / Reference
- 00-1109-114-01 FDA UDI
- Description
- Synthetic Bone Resorbable Graft Stick 5x5x20mm FDA UDI
Identifiers
- Catalog Number
- 00-1109-114-01 FDA UDI
- Primary DI / UDI-DI
- H131001109114011 FDA UDI
- 510(k) Number
- K051774 FDA UDI
- FDA Product Code
- MQV FDA UDI
- GMDN Term
- Bone matrix implant, synthetic, non-antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3045 FDA UDI
- Commercial Distribution
- Not 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
No
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
Yes
FDA UDI
Triosite by Biomatlante — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K051774 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biomatlante
Sources (1)
- FDA UDI d93f2856-e1f1-496f-95d4-754f524d7e37 37 fields · synced May 30, 2026