Identity
- Trade Name
- Endo-Model Knee System - Instruments FDA UDI
- Generic Name
- Patella prosthesis trial FDA UDI
- Device Name
- Patella prosthesis trial - General Instrument FDA UDI
- Model / Reference
- 15-2630/40 FDA UDI
- Description
- Patella prosthesis trial - General Instrument FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04026575187188 FDA UDI
- FDA Product Code
- HWT FDA UDI
- GMDN Term
- Patella prosthesis trial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Patella prosthesis trial
Endo-Model Knee System - Instruments by WALDEMAR LINK GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Patella prosthesis trial.
- Unity Knee System — OMNIlife science, Inc. · Class I
- BIOMET SERIES A — Biomet Orthopedics, Inc. · Class II
- EXULT Knee Replacement System — Corentec Co., Ltd · Class II
- Biomet® Series A™ — Biomet Orthopedics, Inc. · Class II
- Sombrero Patella Trial — TOTAL JOINT ORTHOPEDICS, INC. · Class I
- Biomet® Series A™ — Biomet Orthopedics, Inc. · Class II
- JOURNEY — Smith & Nephew, Inc. · Class II
- Gender Solutions® Natural-Knee® — Zimmer, Inc. · Class I
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
- WALDEMAR LINK GmbH & Co. KG
Sources (1)
- FDA UDI 4274f301-7e5b-4112-8c71-2e5b49e35af0 33 fields · synced May 30, 2026