Freedom® RingLoc® Hip System 11-107223

GUDID 00887868263439

Biomet Orthopedics, LLC

Constrained polyethylene acetabular liner

• Primary Device ID: 00887868263439
• NIH Device Record Key: 5e27d6dc-0adb-4cd0-b39c-05cae60396ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Freedom® RingLoc® Hip System
• Version Model Number: 11-107223
• Catalog Number: 11-107223
• 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	00887868263439 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-19
• Device Publish Date: 2018-10-19

On-Brand Devices [Freedom® RingLoc® Hip System]

• 00887868263477: 11-107227
• 00887868263460: 11-107226
• 00887868263453: 11-107225
• 00887868263446: 11-107224
• 00887868263439: 11-107223
• 00887868263422: 11-107222