M2A MODULAR HEAD HIP SYSTEM 14-380352

GUDID 00880304002609

Biomet Orthopedics, LLC

Metallic femoral head prosthesis

• Primary Device ID: 00880304002609
• NIH Device Record Key: 07412e5b-5255-4ead-adbc-b2105113047e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M2A MODULAR HEAD HIP SYSTEM
• Version Model Number: 14-380352
• Catalog Number: 14-380352
• 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	00880304002609 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043537

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 [M2A MODULAR HEAD HIP SYSTEM]

• 00880304230712: 14-380355
• 00880304230699: 14-380351
• 00880304011205: 14-380353
• 00880304002838: 14-380354
• 00880304002609: 14-380352