Identity
- Trade Name
- Origin Cemented Stem Standard Offset Size 9 FDA UDI
- Generic Name
- Uncoated femoral stem prosthesis, one-piece FDA UDI
- Model / Reference
- 111-42-0902 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09348215054571 FDA UDI
- FDA Product Code
- LZO FDA UDI
- GMDN Term
- Uncoated femoral stem prosthesis, one-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 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
Yes
FDA UDI
Category: Uncoated femoral stem prosthesis, one-piece
Origin Cemented Stem Standard Offset Size 9 by Signature Orthopaedics Pty Ltd — 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
- Signature Orthopaedics Pty Ltd
Sources (1)
- FDA UDI eef1f2e5-d63e-486a-b86b-1f85c61c7190 32 fields · synced Jun 8, 2026