Gemini SL Total Knee System

GUDID 04026575195312

WALDEMAR LINK GmbH & Co. KG

Implantable orthopaedic/craniofacial device connection screw

• Primary Device ID: 04026575195312
• NIH Device Record Key: 62dd86c6-31c2-4d14-9092-37c06962bd6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gemini SL Total Knee System
• Version Model Number: 318-002/00
• Company DUNS: 315675488
• Company Name: WALDEMAR LINK GmbH & Co. KG
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04026575195312 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182872

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-06-09
• Device Publish Date: 2023-01-25

On-Brand Devices [Gemini SL Total Knee System]

• 04026575195312: 318-002/00
• 04026575195305: 318-001/00