Repicci II Resurfacing Knee System CP112353

GUDID 00880304652767

Biomet Sports Medicine, LLC

Tibial insert

• Primary Device ID: 00880304652767
• NIH Device Record Key: 1d2b0c30-c96a-4989-8498-010717b14aa3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Repicci II Resurfacing Knee System
• Version Model Number: CP112353
• Catalog Number: CP112353
• Company DUNS: 627100159
• Company Name: Biomet Sports Medicine, 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: false
• 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@biomet.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304652767 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061681

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: 2016-08-03

On-Brand Devices [Repicci II Resurfacing Knee System]

• 00880304652781: CP112355
• 00880304652767: CP112353
• 00880304652743: CP112351
• 00880304652736: CP112350
• 00880304652729: CP112349