Identity
- Trade Name
- Gemini SL Total Knee System FDA UDI
- Generic Name
- Implantable orthopaedic/craniofacial device connection screw FDA UDI
- Model / Reference
- 318-002/00 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04026575195312 FDA UDI
- 510(k) Number
- K182872 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Implantable orthopaedic/craniofacial device connection screw 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: Implantable orthopaedic/craniofacial device connection screw
Gemini SL Total Knee System by WALDEMAR LINK GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Implantable orthopaedic/craniofacial device connection screw.
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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 62dd86c6-31c2-4d14-9092-37c06962bd6d 33 fields · synced May 30, 2026