VANGUARD XP KNEE SYSTEM 195293

GUDID 00880304556911

Biomet Orthopedics, LLC

Uncoated knee tibia prosthesis, metallic

• Primary Device ID: 00880304556911
• NIH Device Record Key: a69c7e58-7dca-4295-a089-06213064a254
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VANGUARD XP KNEE SYSTEM
• Version Model Number: 195293
• Catalog Number: 195293
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: true
• 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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304556911 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122160

FDA Product Code

• MBV: Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/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: 4
• Public Version Date: 2019-12-11
• Device Publish Date: 2015-10-24

On-Brand Devices [VANGUARD XP KNEE SYSTEM]

• 00880304556928: 195294
• 00880304556911: 195293
• 00880304556904: 195292