FUTURE KNEE 1 Rotating Tibial Insert
Ref 063-5501-0215Model Future Knee 1 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-04049852128346 04049852128346 | Date23 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- Withdrawn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
- Model / reference
- Future Knee 1 System, 063-5501-0215
- Primary DI / UDI-DI
- 04049852128346
- Basic UDI-DI
- B-04049852128346
- EMDN code
- P090903020201 Bicompartmental primary implant mobile bearing tibial inserts
- Device class
- Class III
- System or procedure pack
- System which is a device in itself
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000023586
Other devices from Biotech GmbH
Properties
Other properties (12)
- Sterilise before use: No
- Reusable: No
- Contains latex: No
- Reprocessed single-use device: No
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
- Incorporates a substance derived from human blood or plasma: No
- Contains human tissues or cells: No
- Contains animal tissues or cells: No
- Contains endocrine-disrupting substances: No
- Administering medicine: No
- Measuring function: No
- Incorporates a medicinal substance: No