Endo Model Knee Fusion Nail FK 15-8429/23

GUDID 04026575346691

Tibia Component

WALDEMAR LINK GmbH & Co. KG

Knee arthrodesis prosthesis

• Primary Device ID: 04026575346691
• NIH Device Record Key: 7b1cb639-13c1-4890-910f-526005408ffb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endo Model Knee Fusion Nail FK
• Version Model Number: 15-8429/23
• Catalog Number: 15-8429/23
• 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	04026575346691 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151008

FDA Product Code

• KRO: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, 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 [Endo Model Knee Fusion Nail FK]

• 04026575346752: Femoral Component
• 04026575346745: Femoral Component
• 04026575346738: Femoral Component
• 04026575346721: Femoral Component
• 04026575346714: Femoral Component
• 04026575346707: Femoral Component
• 04026575346691: Tibia Component
• 04026575346684: Tibia Component
• 04026575346677: Tibia Component