ZIPTIGHT FIXATION SYSTEM 909857

GUDID 00880304475854

Biomet Orthopedics, LLC

Ligament bone anchor

• Primary Device ID: 00880304475854
• NIH Device Record Key: 726fcb5d-5cf8-465f-9bff-324d6bdbc5a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZIPTIGHT FIXATION SYSTEM
• Version Model Number: 909857
• Catalog Number: 909857
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00880304475854 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083070

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: 4
• Public Version Date: 2019-01-08
• Device Publish Date: 2015-10-24

On-Brand Devices [ZIPTIGHT FIXATION SYSTEM]

• 00880304476103: 904759
• 00880304476097: 909853
• 00880304475854: 909857
• 00880304473560: 909856