Identity
- Trade Name
- LinkSymphoKnee FDA UDI
- Generic Name
- Knee tibia stem prosthesis FDA UDI
- Device Name
- Modular Stem, Cylindrical Press-Fit, 6 mm Offset FDA UDI
- Model / Reference
- 880-621/10 FDA UDI
- Description
- Modular Stem, Cylindrical Press-Fit, 6 mm Offset FDA UDI
Identifiers
- Catalog Number
- 880-621/10 FDA UDI
- Primary DI / UDI-DI
- 04026575216680 FDA UDI
- 510(k) Number
- K202924 FDA UDI
- FDA Product Code
- JWH FDA UDIHSX FDA UDIHRY FDA UDIKRO FDA UDI
- GMDN Term
- Knee tibia stem prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 FDA UDI888.3520 FDA UDI888.3530 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Knee tibia stem prosthesis
LinkSymphoKnee by WALDEMAR LINK GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Knee tibia stem prosthesis.
- MADISON — Implanet · Class II
- Klassic Knee Tibial Stem Extension, 50mm — TOTAL JOINT ORTHOPEDICS, INC. · Class II
- Klassic Knee Tibial Stem Extension, 75mm — TOTAL JOINT ORTHOPEDICS, INC. · Class II
- MADISON — Implanet · Class II
- Klassic Knee Tibial Stem Extension, 125mm — TOTAL JOINT ORTHOPEDICS, INC. · Class II
- Klassic Knee Tibial Stem Extension, 25mm — TOTAL JOINT ORTHOPEDICS, INC. · Class II
- Klassic Knee Tibial Stem Extension, 100mm — TOTAL JOINT ORTHOPEDICS, INC. · Class II
- MADISON — Implanet · Class II
Cleared under the same submission
K202924 also covers:
- LINK Endo-Model EVO — WALDEMAR LINK GmbH & Co. KG
- LINK Endo-Model EVO — WALDEMAR LINK GmbH & Co. KG
- LINK Endo-Model EVO — WALDEMAR LINK GmbH & Co. KG
- LINK Endo-Model EVO — WALDEMAR LINK GmbH & Co. KG
- LINK Endo-Model EVO — WALDEMAR LINK GmbH & Co. KG
- LINK Endo-Model EVO — WALDEMAR LINK GmbH & Co. KG
- LINK Endo-Model EVO — WALDEMAR LINK GmbH & Co. KG
- LINK Endo-Model EVO — WALDEMAR LINK GmbH & Co. KG
- LINK Endo-Model EVO — WALDEMAR LINK GmbH & Co. KG
- LINK Endo-Model EVO — WALDEMAR LINK GmbH & Co. KG
- LINK Endo-Model EVO — WALDEMAR LINK GmbH & Co. KG
- LINK Endo-Model EVO — 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 7c69c15a-daa7-4734-92a5-2fcc71ab4f67 35 fields · synced May 30, 2026