MAX-TI ACETABULAR 124090

GUDID 00880304225497

Biomet Orthopedics, LLC

Orthopaedic fixation implant alignment tool

• Primary Device ID: 00880304225497
• NIH Device Record Key: 16b8fc49-fbb0-4eb2-a067-28b9ba7c22c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAX-TI ACETABULAR
• Version Model Number: 124090
• Catalog Number: 124090
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00880304225497 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031423

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00880304225497]

Moist Heat or Steam Sterilization

[00880304225497]

Moist Heat or Steam Sterilization

[00880304225497]

Moist Heat or Steam Sterilization

[00880304225497]

Moist Heat or Steam Sterilization

[00880304225497]

Moist Heat or Steam Sterilization

[00880304225497]

Moist Heat or Steam Sterilization

[00880304225497]

Moist Heat or Steam Sterilization

[00880304225497]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [MAX-TI ACETABULAR]

• 00880304301306: 31-105848
• 00880304301290: 31-105844
• 00880304300057: 31-104395
• 00880304225695: 124196
• 00880304225688: 124195
• 00880304225671: 124194
• 00880304225664: 124193
• 00880304225657: 124192
• 00880304225640: 124191
• 00880304225633: 124190
• 00880304225527: 124093
• 00880304225510: 124092
• 00880304225497: 124090
• 00880304225541: 124095
• 00880304225534: 124094
• 00880304225503: 124091