BI-METRIC META-400 HIP SYSTEM CP160400

GUDID 00880304062429

Biomet Orthopedics, LLC

Uncoated femoral stem prosthesis, one-piece

• Primary Device ID: 00880304062429
• NIH Device Record Key: b17e81d2-485e-4ab0-b738-3df38e69e1c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BI-METRIC META-400 HIP SYSTEM
• Version Model Number: CP160400
• Catalog Number: CP160400
• 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	00880304062429 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030055

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 [BI-METRIC META-400 HIP SYSTEM]

• 00880304062436: CP160401
• 00880304062429: CP160400