Distal Assy, PST OFST LVR KJT, 1/4 x 5/8, ALM LMC
by Becker Orthopedic Appliance Company
Ref 1004B4R10Model 1004
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Overview
The Distal Assy, Posterior Offset Lever Lock Knee Joint device is a medical technology product designed to improve knee joint stability and mobility in patients undergoing anterior cruciate ligament (ACL) reconstruction surgery. Featuring a posterior offset lever design, this implant offers enhanced kinematic performance and reduced risk of complications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number19454510046U 00194545067731 | Date13 Dec 2021 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- 1004, 1004B4R10
- Primary DI / UDI-DI
- 00194545067731
- Basic UDI-DI
- 19454510046U
- EMDN Code
- Y06121201 Passive knee-ankle-foot orthoses
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- US-MF-000004002
- Authorised representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Other devices from Becker Orthopedic Appliance Company
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- 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