Avon 6430-0-050

GUDID 07613327049305

Femoral Prosthesis

Howmedica Osteonics Corp.

Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis

• Primary Device ID: 07613327049305
• NIH Device Record Key: e4da91b6-093d-4ed1-9a1b-437dbeae0fd5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avon
• Version Model Number: 6430-0-050
• Catalog Number: 6430-0-050
• 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	07613327049305 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041160

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: 2017-06-19

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