Identity
- Trade Name
- JOURNEY FDA UDI
- Generic Name
- Coated knee tibia prosthesis FDA UDI
- Device Name
- JOURNEY II CR TIBIAL SZ 3-4 RT KIT FDA UDI
- Model / Reference
- 74010079KT FDA UDI
- Description
- JOURNEY II CR TIBIAL SZ 3-4 RT KIT FDA UDI
Identifiers
- Catalog Number
- 74010079KT FDA UDI
- Primary DI / UDI-DI
- 00885556290590 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Coated knee tibia prosthesis FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Coated knee tibia prosthesis
Journey by Smith & Nephew, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coated knee tibia prosthesis.
- ADVANTIM® — MicroPort Orthopedics Inc. · Class II
- Consensus Knee System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- Natural-Knee® — Zimmer, Inc. · Class II
- Balanced Knee System — ORTHO DEVELOPMENT CORP. · Class II
- OMNI Knee — OMNIlife science, Inc. · Class II
- Columbus® CR/PS — AESCULAP, INC. · Class II
- ADVANTIM® — MicroPort Orthopedics Inc. · Class II
- AGC KNEE SYSTEM — Biomet Orthopedics, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI 3ebe6b88-ef5e-4c19-ab97-06d765925b1d 35 fields · synced Jun 8, 2026