Total Elbow 5003-000L

GUDID 07613327014006

Bearing Insert and Bushing

Howmedica Osteonics Corp.

Uncoated elbow humerus prosthesis

• Primary Device ID: 07613327014006
• NIH Device Record Key: 58dc9803-ffb6-4c09-870e-082962275a4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Total Elbow
• Version Model Number: 5003-000L
• Catalog Number: 5003-000L
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	07613327014006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980502

FDA Product Code

• JDC: PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

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 [Total Elbow]

• 07613327014105: Bearing Insert and Bushing
• 07613327014013: Axle Pin
• 07613327014006: Bearing Insert and Bushing
• 07613327013993: Axle Pin