Identity
- Trade Name
- OSTEOFUSE FDA UDI
- Generic Name
- Bone matrix implant, synthetic, non-antimicrobial FDA UDI
- Device Name
- Bioactive Bone Graft Putty is a synthetic bone void filler comprised of a mixture of calcium phosphate granules (CaP) and (45S5) bioactive glass granules suspended in a resorbable alkyleneoxide polymer (AOP) carrier that facilitates handling and delivery of the granule components. The device is supplied as putty, pre-loaded in a syringe applicator and packaged in a sterile barrier foil pouch. The device is provided sterile, for single use, in a variety of sizes. FDA UDI
- Model / Reference
- 3.75g FDA UDI
- Description
- Bioactive Bone Graft Putty is a synthetic bone void filler comprised of a mixture of calcium phosphate granules (CaP) and (45S5) bioactive glass granules suspended in a resorbable alkyleneoxide polymer (AOP) carrier that facilitates handling and delivery of the granule components. The device is supplied as putty, pre-loaded in a syringe applicator and packaged in a sterile barrier foil pouch. The device is provided sterile, for single use, in a variety of sizes. FDA UDI
Identifiers
- Catalog Number
- OF001 FDA UDI
- Primary DI / UDI-DI
- 00816986020082 FDA UDI
- 510(k) Number
- K132071 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bone matrix implant, synthetic, non-antimicrobial
Osteofuse by Bioventus Llc — 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
- Bioventus Llc
Sources (1)
- FDA UDI 7d81895d-7eab-4de2-8982-dde812a1dd44 37 fields · synced May 30, 2026