PRELUDE PF 110018150

GUDID 00880304676831

Biomet Orthopedics, LLC

Patellofemoral joint prosthesis

• Primary Device ID: 00880304676831
• NIH Device Record Key: a50fd0db-ba77-4436-86b4-c4ca2c99f898
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRELUDE PF
• Version Model Number: 110018150
• Catalog Number: 110018150
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	00880304676831 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143543

FDA Product Code

• KRR: PROSTHESIS, KNEE, PATELLO/FEMORAL, 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: 2015-11-16

Devices Manufactured by Biomet Orthopedics, LLC

• 00887868555732 - Patient Specific Planning Solution™: 2024-06-25
• 00880304658462 - Compress®: 2024-05-24
• 00889024663794 - HAMMR™: 2024-05-17
• 00889024663800 - HAMMR™: 2024-05-17
• 00889024663817 - HAMMR™: 2024-05-17
• 00889024663824 - HAMMR™: 2024-05-17
• 00889024663831 - HAMMR™: 2024-05-17
• 00889024663848 - HAMMR™: 2024-05-17