Identity
- Trade Name
- EXPEDIUM FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
- Device Name
- EXPEDIUM SPINE SYSTEM POLYAXIAL SCREW 6.35 x 6 x 70mm FDA UDI
- Model / Reference
- 189612670 FDA UDI
- Description
- EXPEDIUM SPINE SYSTEM POLYAXIAL SCREW 6.35 x 6 x 70mm FDA UDI
Identifiers
- Catalog Number
- 189612670 FDA UDI
- Primary DI / UDI-DI
- 10705034173474 FDA UDI
- FDA Product Code
- MNI FDA UDIMNH FDA UDIKWQ FDA UDIOSH FDA UDINKB FDA UDIKWP FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI888.3060 FDA UDI888.3050 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 4e2da6ce-1ffa-447c-9fd1-e16b1b314efb 36 fields · synced Jun 1, 2026