Regenerex® 141269

GUDID 00887868252204

Biomet Orthopedics, LLC

Coated knee tibia prosthesis Coated knee tibia prosthesis Coated knee tibia prosthesis Coated knee tibia prosthesis

• Primary Device ID: 00887868252204
• NIH Device Record Key: c75894b2-1577-46e1-b5d3-76b2025e5289
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Regenerex®
• Version Model Number: 141269
• Catalog Number: 141269
• 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
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868252204 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080361

FDA Product Code

• MBV: Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/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: 2018-08-23
• Device Publish Date: 2018-07-23

On-Brand Devices [Regenerex®]

• 00887868252280: 184608
• 00887868252273: 184607
• 00887868252266: 184606
• 00887868252259: 184605
• 00887868252242: 184604
• 00887868252235: 184603
• 00887868252228: 184602
• 00887868252211: 184601
• 00887868252204: 141269