Identity
- Trade Name
- BonOs HV FDA UDI
- Generic Name
- Orthopaedic cement, non-antimicrobial FDA UDI
- Device Name
- BonOs® HV is a fast-setting acrylic resin for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant. BonOs® HV cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium. BonOs® HV does not emit a signal and does not pose a safety risk in a magnetic resonance environment. FDA UDI
- Model / Reference
- 1x40 FDA UDI
- Description
- BonOs® HV is a fast-setting acrylic resin for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant. BonOs® HV cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium. BonOs® HV does not emit a signal and does not pose a safety risk in a magnetic resonance environment. FDA UDI
Identifiers
- Catalog Number
- 01-0162 FDA UDI
- Primary DI / UDI-DI
- 04260056882579 FDA UDI
- 510(k) Number
- K210120 FDA UDI
- FDA Product Code
- LOD FDA UDI
- GMDN Term
- Orthopaedic cement, non-antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3027 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
Dimensions & Sizes
- Size
- Weight — 40 Gram FDA UDI
Category: Orthopaedic cement, non-antimicrobial
BonOs HV by OSARTIS GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- OSARTIS GmbH
Sources (1)
- FDA UDI 3faa9394-1921-4b52-8fe9-5f27a398d260 37 fields · synced May 30, 2026