BI-METRIC INTERLOK HIP SYSTEM 12-162301

GUDID 00880304222649

Biomet Orthopedics, LLC

Uncoated femoral stem prosthesis, one-piece

• Primary Device ID: 00880304222649
• NIH Device Record Key: 6a966cae-e6e4-4114-8fba-cf3421ee2371
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BI-METRIC INTERLOK HIP SYSTEM
• Version Model Number: 12-162301
• Catalog Number: 12-162301
• 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	00880304222649 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K931194

FDA Product Code

• JDG: Prosthesis, hip, femoral component, cemented, metal

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 [BI-METRIC INTERLOK HIP SYSTEM]

• 00880304222717: 12-162310
• 00880304222700: 12-162308
• 00880304222687: 12-162306
• 00880304222663: 12-162304
• 00880304222656: 12-162302
• 00880304222649: 12-162301