BIOLOX® OPTION Head System 650-1064

GUDID 00887868248658

Biomet Orthopedics, LLC

Femoral head/stem prosthesis adaptor

• Primary Device ID: 00887868248658
• NIH Device Record Key: 37de7f89-2826-43ed-ad2a-32922093fd9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOLOX® OPTION Head System
• Version Model Number: 650-1064
• Catalog Number: 650-1064
• 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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868248658 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082996

FDA Product Code

• LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

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: 2018-12-14
• Device Publish Date: 2018-11-13

On-Brand Devices [BIOLOX® OPTION Head System]

• 00887868248696: 650-1068
• 00887868248689: 650-1067
• 00887868248672: 650-1066
• 00887868248665: 650-1065
• 00887868248658: 650-1064
• 00887868248641: 650-1063
• 00887868248634: 650-1062
• 00887868248627: 650-1061
• 00887868248610: 650-1060