Biomet® Patellar System 150802

GUDID 00887868241642

Biomet Orthopedics, LLC

Metal-backed patella prosthesis Metal-backed patella prosthesis Metal-backed patella prosthesis Metal-backed patella prosthesis Metal-backed patella prosthesis Metal-backed patella prosthesis Metal-backed patella prosthesis Metal-backed patella prosthesis Metal-backed patella prosthesis Metal-backed patella prosthesis Metal-backed patella prosthesis Metal-backed patella prosthesis Metal-backed patella prosthesis Metal-backed patella prosthesis

• Primary Device ID: 00887868241642
• NIH Device Record Key: 789a98a3-8f6c-43b1-9402-a7383c78886a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biomet® Patellar System
• Version Model Number: 150802
• Catalog Number: 150802
• 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
• 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
• 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
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868241642 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171054

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 [Biomet® Patellar System]

• 00887868344428: 11-150863
• 00887868344411: 11-150862
• 00887868344404: 11-150861
• 00887868344398: 11-150860
• 00887868241666: 150808
• 00887868241659: 150804
• 00887868241642: 150802