Identity
- Trade Name
- LinkSymphoKnee FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- Femoral Cutting Block, CCK, 4-in-1 Cut, Size 3 FDA UDI
- Model / Reference
- 881-115/30 FDA UDI
- Description
- Femoral Cutting Block, CCK, 4-in-1 Cut, Size 3 FDA UDI
Identifiers
- Catalog Number
- 881-115/30 FDA UDI
- Primary DI / UDI-DI
- 04026575305254 FDA UDI
- 510(k) Number
- K202924 FDA UDI
- FDA Product Code
- HSX FDA UDIKRO FDA UDIJWH FDA UDIHRY FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3520 FDA UDI888.3510 FDA UDI888.3560 FDA UDI888.3530 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
LinkSymphoKnee by WALDEMAR LINK GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 f12c4263-ba49-4e21-934a-34b9a9493f7d 35 fields · synced May 31, 2026