Vanguard Removable Molded Poly Tibia SSI002121

GUDID 00880304989146

Biomet Orthopedics, LLC

Knee tibia prosthesis trial

• Primary Device ID: 00880304989146
• NIH Device Record Key: a95d3209-d734-4902-ad9e-94709456d890
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vanguard Removable Molded Poly Tibia
• Version Model Number: SSI002121
• Catalog Number: SSI002121
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• 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: false
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1(800)348-9500
• Email: customerservice@zimmerbiomet.com

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304989146 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060525

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00880304989146]

Moist Heat or Steam Sterilization

[00880304989146]

Moist Heat or Steam Sterilization

[00880304989146]

Moist Heat or Steam Sterilization

[00880304989146]

Moist Heat or Steam Sterilization

[00880304989146]

Moist Heat or Steam Sterilization

[00880304989146]

Moist Heat or Steam Sterilization

[00880304989146]

Moist Heat or Steam Sterilization

[00880304989146]

Moist Heat or Steam Sterilization

[00880304989146]

Moist Heat or Steam Sterilization

[00880304989146]

Moist Heat or Steam Sterilization

[00880304989146]

Moist Heat or Steam Sterilization

[00880304989146]

Moist Heat or Steam Sterilization

[00880304989146]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-07
• Device Publish Date: 2017-05-03

On-Brand Devices [Vanguard Removable Molded Poly Tibia]

• 00880304989153: SSI002122
• 00880304989146: SSI002121
• 00880304989139: SSI002120