BIOLOX DELTA HIP SYSTEM 12-115122

GUDID 00880304591622

Biomet Orthopedics, LLC

Radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator

• Primary Device ID: 00880304591622
• NIH Device Record Key: 99116fc3-a748-4f25-bf18-775be2b97f3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOLOX DELTA HIP SYSTEM
• Version Model Number: 12-115122
• Catalog Number: 12-115122
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	00880304591622 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061312

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: 4
• Public Version Date: 2019-08-09
• Device Publish Date: 2015-10-24

On-Brand Devices [BIOLOX DELTA HIP SYSTEM]

• 00880304591639: 12-115123
• 00880304591622: 12-115122
• 00880304591615: 12-115121
• 00880304591608: 12-115120
• 00880304591585: 12-115109
• 00880304521957: 650-1057
• 00880304521933: 650-1058
• 00880304521896: 650-1056
• 00880304510562: 650-1059
• 00880304448827: 12-115110
• 00880304438804: 12-115115
• 00880304438538: 12-115116
• 00880304438392: 12-115117
• 00880304437548: 12-115111
• 00880304434035: 12-115114
• 05019279316182: 12-115134
• 05019279316175: 12-115133
• 05019279316168: 12-115132
• 05019279316151: 12-115131
• 05019279316144: 12-115130