Knee Instruments 02.18.10.1286
Ref 02.18.10.1286
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 | Number764014274KSR0291N00CW 07630971254213 | Date1 Jun 2026 | StatusActive |
| United States | GUDID listing GUDID | Number07630971254213 | Date17 Feb 2021 | 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- Withdrawn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
- 13 mm distal spacer EUDAMEDKnee Instruments GUDID
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, reusable
- Device Name
- Knee Spacer
- Model / Reference
- 02.18.10.1286
- Primary DI / UDI-DI
- 07630971254213
- Basic UDI-DI
- 764014274KSR0291N00CW
- FDA Product Code
- LXH
- EMDN Code
- L091199 Orthopaedic prosthetics instruments, reusable - other
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, reusable
- Device Class
- Class I
- Regulation Number
- 888.4540
- EU market of registration
- Italy
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Other devices from Medacta International
Properties
Other properties (21)
- Sterile: No
- Single Use: No
- Implantable: 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
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No