Identity
- Trade Name
- Synicem Hip Spacer 48M demo FDA UDI
- Generic Name
- Orthopaedic cement spacer FDA UDI
- Device Name
- DEMONSTRATIVE USE ONLY. NOT FOR USE IN PATIENTS OR FOR SALE Muller Stem Type, 48mm Head, 120 mm Stem Length. Temporary implant which main function is to preserve the articular space during 2 Stage Revision Arthroplasty. Aids in treatment of infection that emerged due to the implant of hip replacement prosthesis. The hip spacer with gentamicin has a surgical steel core coated with radiopaque (barium sulfate) bone cement (PMMA) with antibiotic (gentamicin base). This is a long-term use implant, intended to be used for a maximum period of 180 days. FDA UDI
- Model / Reference
- 881504 FDA UDI
- Description
- DEMONSTRATIVE USE ONLY. NOT FOR USE IN PATIENTS OR FOR SALE Muller Stem Type, 48mm Head, 120 mm Stem Length. Temporary implant which main function is to preserve the articular space during 2 Stage Revision Arthroplasty. Aids in treatment of infection that emerged due to the implant of hip replacement prosthesis. The hip spacer with gentamicin has a surgical steel core coated with radiopaque (barium sulfate) bone cement (PMMA) with antibiotic (gentamicin base). This is a long-term use implant, intended to be used for a maximum period of 180 days. FDA UDI
Identifiers
- Catalog Number
- 881504 FDA UDI
- Primary DI / UDI-DI
- 15060155712823 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic cement spacer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
MR Conditional FDA UDI
Category: Orthopaedic cement spacer
Synicem Hip Spacer 48M demo by Biocomposites Ltd — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Biocomposites Ltd
Sources (1)
- FDA UDI df6fa47f-21a4-4bb1-85f7-e2f660e92e7b 36 fields · synced May 30, 2026