TI SCREW ES 902579

GUDID 00880304404380

Biomet Sports Medicine, LLC

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00880304404380
• NIH Device Record Key: a5655c5c-abfb-4619-bceb-256f4c1d1960
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TI SCREW ES
• Version Model Number: 902579
• Catalog Number: 902579
• Company DUNS: 627100159
• Company Name: Biomet Sports Medicine, 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	00880304404380 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012503

FDA Product Code

• MBI: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-03-21
• Device Publish Date: 2015-10-24

On-Brand Devices [TI SCREW ES]

• 00880304432109: 902482
• 00880304404380: 902579
• 00880304404373: 902578
• 00880304404359: 902576
• 00880304404335: 902574
• 00880304008434: 902556
• 00880304008298: 902554