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 8 x 55mm FDA UDI
- Model / Reference
- 189612855 FDA UDI
- Description
- EXPEDIUM SPINE SYSTEM POLYAXIAL SCREW 6.35 x 8 x 55mm FDA UDI
Identifiers
- Catalog Number
- 189612855 FDA UDI
- Primary DI / UDI-DI
- 10705034173818 FDA UDI
- FDA Product Code
- KWQ FDA UDIMNI FDA UDIKWP FDA UDIOSH FDA UDINKB FDA UDIMNH FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 FDA UDI888.3070 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 59a7d31b-b024-45b2-a957-18f0cc606cd0 36 fields · synced May 31, 2026