FREEDOM ALL POLY HIP SYSTEM 11-107123

GUDID 00880304203594

Biomet Orthopedics, LLC

Constrained polyethylene acetabular liner

• Primary Device ID: 00880304203594
• NIH Device Record Key: 136323a6-7d15-4ba3-bda5-3f3cfe2ee5b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FREEDOM ALL POLY HIP SYSTEM
• Version Model Number: 11-107123
• Catalog Number: 11-107123
• 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 Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304203594 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030047

FDA Product Code

• KWZ: Prosthesis, hip, constrained, cemented or uncemented, 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 [FREEDOM ALL POLY HIP SYSTEM]

• 00880304203655: 11-107128
• 00880304203648: 11-107127
• 00880304203631: 11-107126
• 00880304203624: 11-107125
• 00880304203600: 11-107124
• 00880304203594: 11-107123
• 00880304203587: 11-107122