BIOLOX OPTION HIP SYSTEM 650-1061

GUDID 05019279354214

Biomet Orthopedics, LLC

Femoral head/stem prosthesis adaptor

• Primary Device ID: 05019279354214
• NIH Device Record Key: f668bbf6-de5f-42a6-9354-8307637a18ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOLOX OPTION HIP SYSTEM
• Version Model Number: 650-1061
• Catalog Number: 650-1061
• 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.c

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	05019279354214 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

On-Brand Devices [BIOLOX OPTION HIP SYSTEM]

• 00880304521964: 650-1067
• 00880304521940: 650-1065
• 00880304521926: 650-1064
• 00880304521902: 650-1068
• 00880304520158: 650-1066
• 05019279354252: 650-1063
• 05019279354238: 650-1062
• 05019279354214: 650-1061
• 05019279354191: 650-1060