MARK III CP110461

GUDID 00880304023765

Biomet Orthopedics, LLC

Knee arthroplasty wedge

• Primary Device ID: 00880304023765
• NIH Device Record Key: b81551bb-7cda-46d6-9470-91b40451db54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MARK III
• Version Model Number: CP110461
• Catalog Number: CP110461
• 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	00880304023765 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020381

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

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

Devices Manufactured by Biomet Orthopedics, LLC

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• 00889024684317 - Juggerknot Reusable Fishmouth Guide: 2025-01-21
• 00889024685604 - Jgrknt Reusable Fishmouth Curved Perc Guide: 2025-01-21
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• 00887868578250 - Comprehensive®: 2024-11-13
• 08428898885684 - BIPASS DISPOSABLE PUSHER: 2024-09-11
• 08428898885691 - BIPASS DISPOSABLE PUSHER: 2024-09-11
• 00880304338548 - AGC ANTERIOR FILE: 2024-09-11