M2A MODULAR HIP SYSTEM 11-163689

GUDID 00880304209251

Biomet Orthopedics, LLC

Metallic femoral head prosthesis

• Primary Device ID: 00880304209251
• NIH Device Record Key: 919d2db2-539a-4a02-8c70-ff2dba814e3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M2A MODULAR HIP SYSTEM
• Version Model Number: 11-163689
• Catalog Number: 11-163689
• 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	00880304209251 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003363

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

On-Brand Devices [M2A MODULAR HIP SYSTEM]

• 00880304209282: 11-163692
• 00880304209275: 11-163691
• 00880304209268: 11-163690
• 00880304209251: 11-163689
• 00880304209244: 11-163688
• 00880304209237: 11-163687
• 00880304209220: 11-163686