Identity
- Trade Name
- Synicem Hip Spacer Trial Case (marked) Regular FDA UDI
- Generic Name
- Hip revision prosthesis trial FDA UDI
- Device Name
- Synicem Hip Spacer Trial Case (marked) Regular FDA UDI
- Model / Reference
- 515091 FDA UDI
- Description
- Synicem Hip Spacer Trial Case (marked) Regular FDA UDI
Identifiers
- Catalog Number
- 515091 FDA UDI
- Primary DI / UDI-DI
- 15060155712687 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Hip revision prosthesis trial 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
No
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 Unsafe FDA UDI
Category: Hip revision prosthesis trial
Synicem Hip Spacer Trial Case (marked) Regular by Biocomposites Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hip revision prosthesis trial.
- Prosthesis Trial — ADLER ORTHO SPA · Class I
- Trial shaft — ADLER ORTHO SPA · Class I
- Trial stem — ADLER ORTHO SPA · Class I
- Prosthesis Trial — ADLER ORTHO SPA · Class I
- Trial collar — ADLER ORTHO SPA · Class I
- Trial stem — ADLER ORTHO SPA · Class I
- InterSpace Tapered Wedge Stem Trial — Tecres · Class I
- Trial shaft — ADLER ORTHO SPA · Class I
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 9739a41c-5bba-40ae-b042-77e59abd584e 35 fields · synced Jun 1, 2026