VANGUARD PROVISIONAL TIBIAL BEARING 32-483488

GUDID 00880304611771

Biomet Orthopedics, LLC

Knee tibia prosthesis trial

• Primary Device ID: 00880304611771
• NIH Device Record Key: 7f717c5e-415a-4b23-97d6-4fb0f6fba383
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VANGUARD PROVISIONAL TIBIAL BEARING
• Version Model Number: 32-483488
• Catalog Number: 32-483488
• 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: true
• 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

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
• 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
• 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
• 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 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 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 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	00880304611771 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113550

FDA Product Code

• OIY: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive

Sterilization

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

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

Moist Heat or Steam Sterilization

[00880304611771]

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: 2016-10-21

On-Brand Devices [VANGUARD PROVISIONAL TIBIAL BEARING]

• 00880304611771: 32-483488
• 00880304611764: 32-483486
• 00880304611757: 32-483484
• 00880304611740: 32-483482
• 00880304611733: 32-483480