Super Revo, Hi-Fi
Ref C6140HB, C6141H, C6140H, C6140, C6141
Active
CE MDD
Valid until
Not listed
FDA recalls
None foundDocuments
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-20845854042448 | Date14 Apr 2026 | StatusActive |
| United States | GUDID listing GUDID | Number20845854042448 | Date24 Oct 2015 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls found in the data synced 24 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Super Revo, Hi-FiSuper Revo
- Generic Name
- Tendon/ligament bone anchor, non-bioabsorbable
- Device Name
- Orthopedic, Implant, Non-absorbable, Suture Anchor, Titanium, Shoulder, Super REVO/ThREVO
- Model / Ref / Catalog
- C6140HB, C6141H, C6140H, C6140, C6141
- Primary DI / UDI-DI
- 20845854042448, 20845854019822, 20845854015848, 20845854012311, 20845854019815
- Basic UDI-DI
- B-20845854042448, B-20845854019822, B-20845854015848, B-20845854012311, B-20845854019815
- FDA Product Code
- MBI, MAI
- EMDN Code
- P09120102 Anchors, tendon and ligament synthesis
- GMDN Term
- Tendon/ligament bone anchor, non-bioabsorbable
- Device Class
- Class IIb EUDAMEDClass II GUDID
- Regulation Number
- 888.3040, 888.3030
- EU market of registration
- Belgium
- GUDID distribution status
- In Commercial Distribution
- MRI Safety
- MR Conditional
- Size
- Outer Diameter — 5 Millimeter
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIb | Class II |
Manufacturer details
- EUDAMED SRN
- US-MF-000012663
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Conmed Corporation
Properties
Other properties (18)
- 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
- Manufacturing Date: No