Identity
- Trade Name
- Endo-Model SL Knee Prosthesis System FDA UDI
- Generic Name
- Rotating hinged total knee prosthesis FDA UDI
- Device Name
- Connection Components,Rotational version, neutral FDA UDI
- Model / Reference
- 16-2840/02 FDA UDI
- Description
- Connection Components,Rotational version, neutral FDA UDI
Identifiers
- Catalog Number
- 16-2840/02 FDA UDI
- Primary DI / UDI-DI
- 04026575359233 FDA UDI
- 510(k) Number
- K151008 FDA UDI
- FDA Product Code
- LWJ FDA UDIJDI FDA UDILZO FDA UDIKRO FDA UDI
- GMDN Term
- Rotating hinged total knee prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3360 FDA UDI888.3350 FDA UDI888.3353 FDA UDI888.3510 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: Rotating hinged total knee prosthesis
Endo-Model SL 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 Rotating hinged total knee prosthesis.
- TRIATHLON — Howmedica Osteonics Corp. · Class II
- LEGION — Smith & Nephew, Inc. · Class II
- AS ENDURO — AESCULAP, INC. · Class II
- ATTUNE LPS — DEPUY (IRELAND) · Class II
- TRIATHLON — Howmedica Osteonics Corp. · Class II
- LEGION — Smith & Nephew, Inc. · Class II
- Kinemax — Howmedica Osteonics Corp. · Class II
- TRIATHLON — Howmedica Osteonics Corp. · Class II
Cleared under the same submission
K151008 also covers:
- Endo Model Knee Fusion Nail FK — WALDEMAR LINK GmbH & Co. KG
- Endo Model Knee Fusion Nail FK — WALDEMAR LINK GmbH & Co. KG
- Endo-Model SL Knee Prosthesis System — WALDEMAR LINK GmbH & Co. KG
- Endo-Model SL Knee Prosthesis System — WALDEMAR LINK GmbH & Co. KG
- Endo-Model SL Knee Prosthesis System — WALDEMAR LINK GmbH & Co. KG
- Endo-Model SL Knee Prosthesis System — WALDEMAR LINK GmbH & Co. KG
- Endo-Model SL Knee Prosthesis System — WALDEMAR LINK GmbH & Co. KG
- Endo-Model SL Knee Prosthesis System — WALDEMAR LINK GmbH & Co. KG
- Endo-Model SL Knee Prosthesis System — WALDEMAR LINK GmbH & Co. KG
- Endo-Model SL Knee Prosthesis System — WALDEMAR LINK GmbH & Co. KG
- Endo-Model SL Knee Prosthesis System — WALDEMAR LINK GmbH & Co. KG
- Endo-Model SL Knee Prosthesis 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 e506163a-0139-45a5-8997-94fb54f13a6a 35 fields · synced May 30, 2026