BI-AXIAL™ ELBOW SYSTEM CP562351

GUDID 00880304820913

Biomet Orthopedics, LLC

Hinged total elbow prosthesis

• Primary Device ID: 00880304820913
• NIH Device Record Key: 795b73ef-c644-4e51-a483-43986b8cb8c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BI-AXIAL™ ELBOW SYSTEM
• Version Model Number: CP562351
• Catalog Number: CP562351
• 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: 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

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304820913 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980428

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: 2016-05-05

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• 08428898885691 - BIPASS DISPOSABLE PUSHER: 2024-09-11
• 00880304338548 - AGC ANTERIOR FILE: 2024-09-11
• 00880304339224 - PARALLEL PULLER: 2024-09-11
• 00880304342187 - AGC MODULAR TIBIAL II: 2024-09-11
• 00880304365247 - BIO-MODULAR: 2024-09-11