Peacefx Spinal Posterior Pedicle Fixation Spondylolisthesis Polyaxial Screw
by Artfx Medical LLC 28 variants
Ref 1046050Model Spinal Fixation System
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-00840403805136 00840403805136 | Date5 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- Withdrawn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
- Peacefx Spinal Posterior Pedicle Fixation Spondylolisthesis Polyaxial Screw
- Model / Reference
- Spinal Fixation System, 1046050
- Primary DI / UDI-DI
- 00840403805136
- Basic UDI-DI
- B-00840403805136
- EMDN Code
- P09070302 Thoracolumbosacral fixation systems
- Device Class
- Class IIb
- EU market of registration
- Malta
Manufacturer details
- EUDAMED SRN
- US-MF-000023267
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from Artfx Medical LLC
Properties
Other properties (10)
- Sterile: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No