VANGUARD 360 KNEE SYSTEM 185536

GUDID 00880304555815

Biomet Orthopedics, LLC

Knee arthroplasty wedge

• Primary Device ID: 00880304555815
• NIH Device Record Key: 60d79c0f-597f-440b-9006-b48cc9f42f7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VANGUARD 360 KNEE SYSTEM
• Version Model Number: 185536
• Catalog Number: 185536
• 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	00880304555815 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140883

FDA Product Code

• MBH: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

On-Brand Devices [VANGUARD 360 KNEE SYSTEM]

• 00880304672482: 185553
• 00880304672475: 185552
• 00880304672468: 185551
• 00880304672451: 185550
• 00880304555839: 185538
• 00880304555822: 185537
• 00880304555815: 185536
• 00880304555808: 185535
• 00880304555792: 185533
• 00880304555785: 185532
• 00880304555778: 185531
• 00880304555761: 185530