Usmart Polyaxial Reduction Cannulated Pedicle Screw
by Beijing Fule Science & Technology Development Co., Ltd. 13 variants
Ref 0110675040
Active
CE MDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-06942072913915 06942072913915 | Date26 Oct 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device name
- Posterior Spinal Screw-rod System
- Model / reference
- 0110675040
- Primary DI / UDI-DI
- 06942072913915
- Basic UDI-DI
- B-06942072913915
- EMDN code
- P09070302 Thoracolumbosacral fixation systems
- Device class
- Class IIb
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Czechia
Manufacturer details
- EUDAMED SRN
- CN-MF-000006511
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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Properties
Other properties (10)
- Supplied sterile: No
- Reusable: No
- Contains latex: No
- Reprocessed single-use device: No
- Incorporates a substance derived from human blood or plasma: No
- Contains human tissues or cells: No
- Contains animal tissues or cells: No
- Administering medicine: No
- Measuring function: No
- Incorporates a medicinal substance: No