TI REPICCI II KNEE SYSTEM CP112957

GUDID 00880304653078

Biomet Orthopedics, LLC

Uncoated unicondylar knee femur prosthesis

• Primary Device ID: 00880304653078
• NIH Device Record Key: 0c6ac1b7-4ed8-47e7-8e80-41959d94e371
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TI REPICCI II KNEE SYSTEM
• Version Model Number: CP112957
• Catalog Number: CP112957
• 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	00880304653078 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063515

FDA Product Code

• HRY: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

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: 2016-09-26

On-Brand Devices [TI REPICCI II KNEE SYSTEM]

• 00880304653092: CP112959
• 00880304653078: CP112957