Identity
- Trade Name
- OSTEOPAL® FDA UDI
- Generic Name
- Orthopaedic cement, non-antimicrobial FDA UDI
- Device Name
- OSTEOPAL® plus is a radiopaque, low-viscosity bone cement, based on polymethyl methacrylate with an extended application phase, used to fill and stabilize vertebral bodies. OSTEOPAL® plus contains zirconium dioxide as an X-ray contrast agent. OSTEOPAL® plus contains the coloring agent chlorophyll VIII (E141) to improve visibility in the surgical field. The bone cement is prepared immediately prior to use by mixing the polymer powder component and the liquid monomer component. A low viscosity paste is applied with the use of application system, placed in the vertebral body, where it cures. OSTEOPAL® plus conforms to ISO 5833 except Annex C FDA UDI
- Model / Reference
- plus FDA UDI
- Description
- OSTEOPAL® plus is a radiopaque, low-viscosity bone cement, based on polymethyl methacrylate with an extended application phase, used to fill and stabilize vertebral bodies. OSTEOPAL® plus contains zirconium dioxide as an X-ray contrast agent. OSTEOPAL® plus contains the coloring agent chlorophyll VIII (E141) to improve visibility in the surgical field. The bone cement is prepared immediately prior to use by mixing the polymer powder component and the liquid monomer component. A low viscosity paste is applied with the use of application system, placed in the vertebral body, where it cures. OSTEOPAL® plus conforms to ISO 5833 except Annex C FDA UDI
Identifiers
- Catalog Number
- 66045747 FDA UDI
- Primary DI / UDI-DI
- 04260102132597 FDA UDI
- 510(k) Number
- K153737 FDA UDI
- FDA Product Code
- LOD FDA UDINDN 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
Category: Orthopaedic cement, non-antimicrobial
Osteopal® by Heraeus Medical LLC — 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
- Heraeus Medical LLC
Sources (1)
- FDA UDI d901af8b-7469-4824-8a68-eb3646fd8d01 35 fields · synced May 30, 2026