Identity
- Trade Name
- Bi-Ostetic Bioactive Glass Foam FDA UDI
- Generic Name
- Bone matrix implant, synthetic, non-antimicrobial FDA UDI
- Device Name
- Bi-Ostetic Bioactive Glass Foam is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) – tri-calcium phosphate (TCP) granules and 45S5 bioactive glass granules. The bovine fibrillar collagen component is biocompatible and the 45S5 glass particles are bioactive. Bi-Ostetic Bioactive Glass Foam is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The graft resorbs and is replaced by the growth of new bone during the healing process. Bi-Ostetic Bioactive Glass Foam must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine. FDA UDI
- Model / Reference
- AA-01P FDA UDI
- Description
- Bi-Ostetic Bioactive Glass Foam is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) – tri-calcium phosphate (TCP) granules and 45S5 bioactive glass granules. The bovine fibrillar collagen component is biocompatible and the 45S5 glass particles are bioactive. Bi-Ostetic Bioactive Glass Foam is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The graft resorbs and is replaced by the growth of new bone during the healing process. Bi-Ostetic Bioactive Glass Foam must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine. FDA UDI
Identifiers
- Catalog Number
- AA-01P FDA UDI
- Primary DI / UDI-DI
- 00816125023783 FDA UDI
- 510(k) Number
- K170917 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
- 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
Category: Bone matrix implant, synthetic, non-antimicrobial
Bi-Ostetic Bioactive Glass Foam by Berkeley Advanced Biomaterials — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K170917 also covers:
- AlexiGlass Bioactive Glass Putty — Berkeley Advanced Biomaterials
- AlexiGlass Bioactive Glass Putty — Berkeley Advanced Biomaterials
- AlexiGlass Bioactive Glass Putty — Berkeley Advanced Biomaterials
- AlexiGlass Bioactive Glass Putty — Berkeley Advanced Biomaterials
- AlexiGlass Bioactive Glass Strip — Berkeley Advanced Biomaterials
- AlexiGlass Bioactive Glass Strip — Berkeley Advanced Biomaterials
- AlexiGlass Bioactive Glass Strip — Berkeley Advanced Biomaterials
- AlexiGlass Bioactive Glass Strip — Berkeley Advanced Biomaterials
- AlexiGlass Bioactive Glass Strip — Berkeley Advanced Biomaterials
- Bi-Ostetic Bioactive Glass Foam — Berkeley Advanced Biomaterials
- Bi-Ostetic Bioactive Glass Foam — Berkeley Advanced Biomaterials
- Bi-Ostetic Bioactive Glass Foam — Berkeley Advanced Biomaterials
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
- Berkeley Advanced Biomaterials
Sources (1)
- FDA UDI d09907b9-87ed-411f-9bf8-fa8e05775029 35 fields · synced May 30, 2026