Endo Model Knee Fusion Nail FK 15-8430/23

GUDID 04026575346721

Femoral Component

WALDEMAR LINK GmbH & Co. KG

Knee arthrodesis prosthesis Knee arthrodesis prosthesis Knee arthrodesis prosthesis Knee arthrodesis prosthesis Knee arthrodesis prosthesis Knee arthrodesis prosthesis Knee arthrodesis prosthesis Knee arthrodesis prosthesis Knee arthrodesis prosthesis Knee arthrodesis prosthesis Knee arthrodesis prosthesis Knee arthrodesis prosthesis Knee arthrodesis prosthesis Knee arthrodesis prosthesis Knee arthrodesis prosthesis

• Primary Device ID: 04026575346721
• NIH Device Record Key: 39e8481d-440f-4233-ba6b-2469671e4458
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endo Model Knee Fusion Nail FK
• Version Model Number: 15-8430/23
• Catalog Number: 15-8430/23
• 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	04026575346721 [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