SUPERIOR-LOC HIP SYSTEM 15-103571

GUDID 00880304237100

Biomet Orthopedics, LLC

Non-constrained polyethylene acetabular liner

• Primary Device ID: 00880304237100
• NIH Device Record Key: 19a982fa-b509-4b0e-8284-a46c7d35d53e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SUPERIOR-LOC HIP SYSTEM
• Version Model Number: 15-103571
• Catalog Number: 15-103571
• 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	00880304237100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K911718

FDA Product Code

• JDI: Prosthesis, hip, semi-constrained, metal/polymer, 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: 2015-10-24

On-Brand Devices [SUPERIOR-LOC HIP SYSTEM]

• 00880304237216: 15-103585
• 00880304237209: 15-103584
• 00880304237193: 15-103583
• 00880304237186: 15-103582
• 00880304237179: 15-103578
• 00880304237162: 15-103577
• 00880304237155: 15-103576
• 00880304237148: 15-103575
• 00880304237131: 15-103574
• 00880304237124: 15-103573
• 00880304237117: 15-103572
• 00880304237100: 15-103571