Active Articulation 010000991

GUDID 00880304527393

Biomet Orthopedics, LLC

Non-constrained polyethylene acetabular liner

• Primary Device ID: 00880304527393
• NIH Device Record Key: 59b65251-97fc-4d6e-87a2-1288a7aef422
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Active Articulation
• Version Model Number: 010000991
• Catalog Number: 010000991
• 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
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304527393 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110555

FDA Product Code

• KWY: Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

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: 2020-05-25
• Device Publish Date: 2020-05-15

On-Brand Devices [Active Articulation]

• 00880304527416: 010000993
• 00880304527409: 010000992
• 00880304520042: 592806
• 00880304527393: 010000991
• 00880304527386: 010000990