Modular Head Hip System 163713

GUDID 00887868310898

Biomet Orthopedics, LLC

Press-fit femoral stem prosthesis

• Primary Device ID: 00887868310898
• NIH Device Record Key: 91234838-748a-4656-9199-2506b06887a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Modular Head Hip System
• Version Model Number: 163713
• Catalog Number: 163713
• 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	00887868310898 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K921277

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-02-15

On-Brand Devices [Modular Head Hip System]

• 00880304256910: 163713
• 00887868310898: 163713