INTEGRAL HIP SYSTEM 11-162615

GUDID 00880304208568

Biomet Orthopedics, LLC

Coated hip femur prosthesis, modular

• Primary Device ID: 00880304208568
• NIH Device Record Key: 0d5ee26c-e99f-4370-aa5b-dcab4f053255
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTEGRAL HIP SYSTEM
• Version Model Number: 11-162615
• Catalog Number: 11-162615
• 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	00880304208568 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K984296

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

On-Brand Devices [INTEGRAL HIP SYSTEM]

• 00880304208643: 11-162678
• 00880304208636: 11-162676
• 00880304208629: 11-162674
• 00880304208612: 11-162672
• 00880304208582: 11-162619
• 00880304208568: 11-162615
• 00880304208551: 11-162613
• 00880304208544: 11-162611
• 00880304208537: 11-162609