Identity
- Trade Name
- Endo-Model Knee System - Instruments FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- Orthopaedic implant aiming/guiding block, reusable - Endo Model Knee System FDA UDI
- Model / Reference
- 151-210/01 FDA UDI
- Description
- Orthopaedic implant aiming/guiding block, reusable - Endo Model Knee System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04026575290222 FDA UDI
- 510(k) Number
- K220628 FDA UDI
- FDA Product Code
- KRO FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable 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
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
No
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: Orthopaedic prosthesis implantation positioning instrument, reusable
Endo-Model Knee System - Instruments by WALDEMAR LINK GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic prosthesis implantation positioning instrument, reusable.
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- ARCADIUS XP C — AESCULAP, INC. · Class I
- LUCENT — SPINAL ELEMENTS, INC. · Class I
- U-KneeTec — CORIN LTD · Class II
- NCB® — Zimmer, Inc. · Class II
Cleared under the same submission
K220628 also covers:
- Endo-Model Knee System - Instruments — WALDEMAR LINK GmbH & Co. KG
- Endo-Model Knee System - Instruments — WALDEMAR LINK GmbH & Co. KG
- Endo-Model Knee System - Instruments — WALDEMAR LINK GmbH & Co. KG
- Endo-Model Knee System - Instruments — WALDEMAR LINK GmbH & Co. KG
- Endo-Model Knee System - Instruments — WALDEMAR LINK GmbH & Co. KG
- Endo-Model Knee System - Instruments — WALDEMAR LINK GmbH & Co. KG
- LINK Endo-Model EVO Knee System — WALDEMAR LINK GmbH & Co. KG
- LINK Endo-Model EVO Knee System — WALDEMAR LINK GmbH & Co. KG
- LINK Endo-Model EVO Knee System — WALDEMAR LINK GmbH & Co. KG
- LINK Endo-Model EVO Knee System — WALDEMAR LINK GmbH & Co. KG
- LINK Endo-Model EVO Knee System — WALDEMAR LINK GmbH & Co. KG
- LINK Endo-Model EVO Knee System — WALDEMAR LINK GmbH & Co. KG
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 d4374f7c-993a-4ef0-9e35-7c48c9db2f37 34 fields · synced May 31, 2026