Identity
- Trade Name
- Gemini SL FDA UDI
- Generic Name
- Uncoated knee tibia prosthesis, polyethylene FDA UDI
- Device Name
- Articulating Surface - fixed bearing FDA UDI
- Model / Reference
- 318-238/10 FDA UDI
- Description
- Articulating Surface - fixed bearing FDA UDI
Identifiers
- Catalog Number
- 318-238/10 FDA UDI
- Primary DI / UDI-DI
- 04026575406869 FDA UDI
- 510(k) Number
- K182872 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Uncoated knee tibia prosthesis, polyethylene FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 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: Uncoated knee tibia prosthesis, polyethylene
Gemini SL by WALDEMAR LINK GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uncoated knee tibia prosthesis, polyethylene.
- Freedom — MAXX ORTHOPEDICS INC. · Class II
- JOURNEY — Smith & Nephew, Inc. · Class II
- JII — Smith & Nephew, Inc. · Class II
- World Knee Vit-E CR All Poly Tibia — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- Freedom — MAXX ORTHOPEDICS INC. · Class II
- TC-PLUS Primary — Smith & Nephew, Inc. · Class II
- Triathlon — Howmedica Osteonics Corp. · Class II
- Freedom — MAXX ORTHOPEDICS INC. · Class II
Cleared under the same submission
K182872 also covers:
- Gemini SL — WALDEMAR LINK GmbH & Co. KG
- Gemini SL — WALDEMAR LINK GmbH & Co. KG
- Gemini SL — WALDEMAR LINK GmbH & Co. KG
- Gemini SL — WALDEMAR LINK GmbH & Co. KG
- Gemini SL — WALDEMAR LINK GmbH & Co. KG
- Gemini SL — WALDEMAR LINK GmbH & Co. KG
- Gemini SL — WALDEMAR LINK GmbH & Co. KG
- Gemini SL — WALDEMAR LINK GmbH & Co. KG
- Gemini SL — WALDEMAR LINK GmbH & Co. KG
- Gemini SL — WALDEMAR LINK GmbH & Co. KG
- Gemini SL — WALDEMAR LINK GmbH & Co. KG
- Gemini SL — 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 9848d6e4-a26b-4875-a349-e325a8d05621 35 fields · synced Jun 8, 2026