Identity
- Trade Name
- Allogran-R® FDA UDI
- Generic Name
- Synthetic bone graft FDA UDI
- Device Name
- Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is provided sterile for single patient use. The biodegradable, radiopaque granules/blocks are resorbed in approximately 6-12 months when used in accordance with the device labelling. Biocomposites Tri-Calcium Phosphate Bone Graft Substitute is manufactured from medical grade Tri-Calcium Phosphate. Numerous bone graft operations are undertaken every year to repair bone defects caused by surgery, tumours, trauma, infections and other damage. Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is intended for use in clinical situations where the use of autologous grafts or other bone graft substitutes maybe undesirable, due either to the risk of associated infection or unavailability. Allogran-R® resorbs and is replaced with bone during the healing process. FDA UDI
- Model / Reference
- 800-010 FDA UDI
- Description
- Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is provided sterile for single patient use. The biodegradable, radiopaque granules/blocks are resorbed in approximately 6-12 months when used in accordance with the device labelling. Biocomposites Tri-Calcium Phosphate Bone Graft Substitute is manufactured from medical grade Tri-Calcium Phosphate. Numerous bone graft operations are undertaken every year to repair bone defects caused by surgery, tumours, trauma, infections and other damage. Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is intended for use in clinical situations where the use of autologous grafts or other bone graft substitutes maybe undesirable, due either to the risk of associated infection or unavailability. Allogran-R® resorbs and is replaced with bone during the healing process. FDA UDI
Identifiers
- Catalog Number
- 800-010 FDA UDI
- Primary DI / UDI-DI
- 15060155710034 FDA UDI
- 510(k) Number
- K061311 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
Allogran-R® by Biocomposites Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K061311 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
- Biocomposites Ltd
Sources (1)
- FDA UDI e552cb02-7860-417f-a4b8-d954e7172a77 38 fields · synced May 30, 2026