Identity
- Trade Name
- PALACOS FDA UDI
- Generic Name
- Orthopaedic cement, non-antimicrobial FDA UDI
- Device Name
- PALACOS® R is a fast-curing, radiopaque, poly(methyl methacrylate)-based bone cement. PALACOS ® R contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field PALACOS ® R has been coloured with chlorophyll (E141). The bone cement is prepared directly before use by mixing a polymer powder component with a liquid monomer component. A ductile dough forms which cures within a few minutes. FDA UDI
- Model / Reference
- R FDA UDI
- Description
- PALACOS® R is a fast-curing, radiopaque, poly(methyl methacrylate)-based bone cement. PALACOS ® R contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field PALACOS ® R has been coloured with chlorophyll (E141). The bone cement is prepared directly before use by mixing a polymer powder component with a liquid monomer component. A ductile dough forms which cures within a few minutes. FDA UDI
Identifiers
- Catalog Number
- 00-1112-140-01 FDA UDI
- Primary DI / UDI-DI
- J014002112140011 FDA UDI
- 510(k) Number
- K030902 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
- Not 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
Palacos by Heraeus Medical LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K030902 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
- Heraeus Medical LLC
Sources (1)
- FDA UDI b6c6fb4f-4c1b-4cd0-8bf7-9340f861895c 37 fields · synced Jun 1, 2026