Expedium Spine System
by Medos International SARL 909 variants
Ref 175491150Model EXPEDIUM Spine System Locking Component
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0705034a001635Z | Date18 Mar 2026 | StatusActive |
| United States | GUDID listing GUDID | Number10705034032467 | Date24 Sep 2015 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Expedium Spine System EUDAMEDExpedium GUDID
- Generic Name
- Spinal bone set screw
- Device Name
- Slotted washer, Bolt Polyaxial Washer, Polyaxial Washer, Domed Lock Nut, Swivel, Domed Lock Nut, Domed Nut, Lock Nut, Outerring Nut, etc.
- Model / Ref / Catalog
- EXPEDIUM Spine System Locking Component, 175491150
- Primary DI / UDI-DI
- 10705034032467
- Basic UDI-DI
- 0705034a001635Z
- FDA Product Code
- NKB, KWQ, MNH, KWP, OSH, MNI
- EMDN Code
- P09070302 Thoracolumbosacral fixation systems
- GMDN Term
- Spinal bone set screw
- Device Class
- Class IIb EUDAMEDClass II GUDID
- Regulation Number
- 888.3070, 888.3060, 888.3050
- Market of Registration
- Belgium
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIb | Class II |
Manufacturer details
- EUDAMED SRN
- CH-MF-000014268
- Authorised representative
- DePuy Ireland UC IE-AR-000009328
Other devices from Medos International SARL
Properties
Other properties (20)
- Sterile: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No