Ti Repicci II® Knee System CP112962

GUDID 00880304653122

Biomet Orthopedics, LLC

Femoral stem centralizer

• Primary Device ID: 00880304653122
• NIH Device Record Key: 56071a28-55b2-4028-923c-0669315806a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ti Repicci II® Knee System
• Version Model Number: CP112962
• Catalog Number: CP112962
• 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	00880304653122 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-09
• Device Publish Date: 2018-06-08

On-Brand Devices [Ti Repicci II® Knee System]

• 00880304653153: CP112965
• 00880304653146: CP112964
• 00880304653139: CP112963
• 00880304653122: CP112962
• 00880304653115: CP112961
• 00880304653108: CP112960
• 00880304653085: CP112958
• 00880304653061: CP112956
• 00880304653054: CP112955
• 00880304653047: CP112954