Identity
- Trade Name
- Synicem Shoulder Spacer H48 demo FDA UDI
- Generic Name
- Orthopaedic cement spacer FDA UDI
- Device Name
- DEMONSTRATIVE USE ONLY. NOT FOR USE IN PATIENTS OR FOR SALE 48mm Head, 120 mm Stem Length Shoulder spacer with gentamicin is a temporary implant whose main function is to maintain joint space in the interval between 2 stage revision arthroplasties. Aids in treatment of infection originating in the implant of shoulder prosthesis. Shoulder spacer has a surgical steel center 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
- 881505 FDA UDI
- Description
- DEMONSTRATIVE USE ONLY. NOT FOR USE IN PATIENTS OR FOR SALE 48mm Head, 120 mm Stem Length Shoulder spacer with gentamicin is a temporary implant whose main function is to maintain joint space in the interval between 2 stage revision arthroplasties. Aids in treatment of infection originating in the implant of shoulder prosthesis. Shoulder spacer has a surgical steel center 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
- 881505 FDA UDI
- Primary DI / UDI-DI
- 15060155712830 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 Shoulder Spacer H48 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 7de0aa9c-4b9d-4861-a56e-fb79101c6050 36 fields · synced May 30, 2026