Prelude® PF 110005116

GUDID 00887868343599

Biomet Orthopedics, LLC

Patellofemoral joint prosthesis

• Primary Device ID: 00887868343599
• NIH Device Record Key: 445bd32a-6cff-4022-b838-987a9307a71c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prelude® PF
• Version Model Number: 110005116
• Catalog Number: 110005116
• 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	00887868343599 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123907

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-21
• Device Publish Date: 2019-10-11

On-Brand Devices [Prelude® PF]

• 00887868343735: 110018164
• 00887868343728: 110018156
• 00887868343711: 110018155
• 00887868343704: 110018154
• 00887868343698: 110018153
• 00887868343681: 110018152
• 00887868343674: 110018151
• 00887868343667: 110018150
• 00887868343650: 110018149
• 00887868343643: 110018148
• 00887868343636: 110005120
• 00887868343629: 110005119
• 00887868343612: 110005118
• 00887868343605: 110005117
• 00887868343599: 110005116
• 00887868343582: 110005115
• 00887868343575: 110004335
• 00887868343568: 110004334
• 00887868343551: 110004333
• 00887868343544: 110004332
• 00887868343537: 110004331
• 00887868343520: 110004330