TrabecuLink Tibial Cone 15-2994/04

GUDID 04026575192571

TrabecuLink Tibial Cone / half

WALDEMAR LINK GmbH & Co. KG

Knee arthroplasty wedge

• Primary Device ID: 04026575192571
• NIH Device Record Key: b4a92db6-8703-49d9-b8c7-89dfee16d1fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TrabecuLink Tibial Cone
• Version Model Number: 15-2994/04
• Catalog Number: 15-2994/04
• 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: false
• 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	04026575192571 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200113

FDA Product Code

• MBH: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-20
• Device Publish Date: 2021-01-12

On-Brand Devices [TrabecuLink Tibial Cone]

• 04026575076536: TrabecuLink Tibial Cone / full
• 04026575192588: TrabecuLink Tibial Cone / half
• 04026575192571: TrabecuLink Tibial Cone / half
• 04026575192557: TrabecuLink Tibial Cone / left half
• 04026575192540: TrabecuLink Tibial Cone / right half
• 04026575192526: TrabecuLink Tibial Cone / full
• 04026575192489: TrabecuLink Tibial Cone / left half
• 04026575192472: TrabecuLink Tibial Cone / right half
• 04026575192465: TrabecuLink Tibial Cone / full
• 04026575192458: TrabecuLink Tibial Cone / half
• 04026575192441: TrabecuLink Tibial Cone / left half
• 04026575192434: TrabecuLink Tibial Cone / right half
• 04026575192427: TrabecuLink Tibial Cone / full
• 04026575192410: TrabecuLink Tibial Cone / half
• 04026575192403: TrabecuLink Tibial Cone / left half
• 04026575187799: TrabecuLink Tibial Cone / right half