TiMAX® 814027046

GUDID 00887868548314

Biomet Orthopedics, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00887868548314
• NIH Device Record Key: 372fc51c-81c0-4eaf-98fb-c76d016bbe10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TiMAX®
• Version Model Number: 8140-27-046
• Catalog Number: 814027046
• 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: 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
• 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 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 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	00887868548314 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083843

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[00887868548314]

Moist Heat or Steam Sterilization

[00887868548314]

Moist Heat or Steam Sterilization

[00887868548314]

Moist Heat or Steam Sterilization

[00887868548314]

Moist Heat or Steam Sterilization

[00887868548314]

Moist Heat or Steam Sterilization

[00887868548314]

Moist Heat or Steam Sterilization

[00887868548314]

Moist Heat or Steam Sterilization

[00887868548314]

Moist Heat or Steam Sterilization

[00887868548314]

Moist Heat or Steam Sterilization

[00887868548314]

Moist Heat or Steam Sterilization

[00887868548314]

Moist Heat or Steam Sterilization

[00887868548314]

Moist Heat or Steam Sterilization

[00887868548314]

Moist Heat or Steam Sterilization

[00887868548314]

Moist Heat or Steam Sterilization

[00887868548314]

Moist Heat or Steam Sterilization

[00887868548314]

Moist Heat or Steam Sterilization

[00887868548314]

Moist Heat or Steam Sterilization

[00887868548314]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-23
• Device Publish Date: 2022-11-15

On-Brand Devices [TiMAX®]

• 00887868548277: 8140-27-038
• 00887868548352: 8140-27-060
• 00887868548345: 8140-27-055
• 00887868548338: 8140-27-050
• 00887868548321: 8140-27-048
• 00887868548314: 8140-27-046
• 00887868548307: 8140-27-044
• 00887868548291: 8140-27-042
• 00887868548284: 8140-27-040
• 00887868548260: 8140-27-036
• 00887868548253: 8140-27-034
• 00887868548246: 8140-27-032
• 00887868548239: 8140-27-030
• 00887868548222: 8140-27-028
• 00887868548215: 8140-27-026
• 00887868548208: 8140-27-024
• 00887868548192: 8140-27-022
• 00887868548185: 8140-27-020
• 00887868548178: 8140-27-018
• 00887868548161: 8140-27-016
• 00887868548154: 8140-27-014
• 00887868548147: 8140-27-012
• 00887868548130: 8140-27-010