Identity
- Trade Name
- Endo-Model Modular Knee Prosthesis System FDA UDI
- Generic Name
- Uncoated knee tibia/insert prosthesis FDA UDI
- Device Name
- Rotational Knee Joint Prosthesis,Tibial component FDA UDI
- Model / Reference
- 15-2814/01 FDA UDI
- Description
- Rotational Knee Joint Prosthesis,Tibial component FDA UDI
Identifiers
- Catalog Number
- 15-2814/01 FDA UDI
- Primary DI / UDI-DI
- 04026575316243 FDA UDI
- FDA Product Code
- KRO FDA UDI
- GMDN Term
- Uncoated knee tibia/insert prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3510 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Uncoated knee tibia/insert prosthesis
Endo-Model Modular Knee Prosthesis System by WALDEMAR LINK GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uncoated knee tibia/insert prosthesis.
- Arthrex® — Arthrex, Inc. · Class II
- Vanguard Complete Knee System — Biomet Orthopedics, Inc. · Class II
- Arthrex® — Arthrex, Inc. · Class II
- LOSPA Total Knee System — Corentec Co., Ltd · Class II
- LOSPA Total Knee System — Corentec Co., Ltd · Class II
- LOSPA Modular Knee System — Corentec Co., Ltd · Class II
- Arthrex® — Arthrex, Inc. · Class II
- LOSPA Modular Knee System — Corentec Co., Ltd · 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 II | Pending data |
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Manufacturer
- Manufacturer
- WALDEMAR LINK GmbH & Co. KG
Sources (1)
- FDA UDI 9ecf0b3a-a8df-4500-b894-3d290ede2f2c 34 fields · synced May 30, 2026