Identity
- Trade Name
- EXPEDIUM FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
- Device Name
- EXPEDIUM SPINE SYSTEM POLYAXIAL BOLT, STANDARD 10 x 55mm FDA UDI
- Model / Reference
- 175412055 FDA UDI
- Description
- EXPEDIUM SPINE SYSTEM POLYAXIAL BOLT, STANDARD 10 x 55mm FDA UDI
Identifiers
- Catalog Number
- 175412055 FDA UDI
- Primary DI / UDI-DI
- 10705034025537 FDA UDI
- FDA Product Code
- KWP FDA UDIKWQ FDA UDINKB FDA UDIMNH FDA UDIMNI FDA UDIOSH FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3050 FDA UDI888.3060 FDA UDI888.3070 FDA UDI
- Commercial Distribution
- Not 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Expedium by Medos International Sàrl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Medos International Sàrl
Sources (1)
- FDA UDI 33e38f02-b857-4e8e-8a16-87eb86226898 36 fields · synced Jun 1, 2026