IO FiX 2.0
by Extremity Medical, LLC 30 variants
Ref 118-43034-S
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-00842078120736 00842078120736 | Date18 Aug 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- Withdrawn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
- Ø4.3 Tapered Locking Screw x 34mm (Sterile)
- Model / Reference
- 118-43034-S
- Primary DI / UDI-DI
- 00842078120736
- Basic UDI-DI
- B-00842078120736
- EMDN Code
- P09120603 Cannulated screws
- Device Class
- Class IIb
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- US-MF-000018334
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Extremity Medical, LLC
Properties
Other properties (9)
- 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