Avon 6430-0-200

GUDID 07613327049404

Femoral Prosthesis

Howmedica Osteonics Corp.

Polyethylene patella prosthesis

• Primary Device ID: 07613327049404
• NIH Device Record Key: f011ef8e-6631-4ba4-96c5-525def3546d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avon
• Version Model Number: 6430-0-200
• Catalog Number: 6430-0-200
• Company DUNS: 058311945
• Company Name: Howmedica Osteonics Corp.
• Device Count: 1
• DM Exempt: false
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327049404 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020841

FDA Product Code

• HRY: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [Avon]

• 07613327049404: Femoral Prosthesis
• 07613327049350: Femoral Joint Patella Component
• 07613327049343: Femoral Prosthesis
• 07613327049336: Femoral Prosthesis
• 07613327049329: Femoral Joint Patella Component
• 07613327049312: Femoral Joint Patella Component
• 07613327049305: Femoral Prosthesis