MAXFIRE 900339

GUDID 00880304460454

Biomet Sports Medicine, LLC

Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable

• Primary Device ID: 00880304460454
• NIH Device Record Key: aaec95c0-2f59-4201-82a4-23905f13e30b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAXFIRE
• Version Model Number: 900339
• Catalog Number: 900339
• Company DUNS: 627100159
• Company Name: Biomet Sports Medicine, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304460454 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061776

FDA Product Code

• JDR: STAPLE, FIXATION, BONE

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: 2020-05-06
• Device Publish Date: 2015-10-24

Devices Manufactured by Biomet Sports Medicine, LLC

• 00880304460454 - MAXFIRE: 2020-05-06
• 00880304460454 - MAXFIRE: 2020-05-06
• 00880304475915 - MAXFIRE MARXMEN: 2020-05-06
• 00880304475922 - MAXFIRE MARXMEN: 2020-05-06
• 00880304477193 - JUGGERKNOT SOFT ANCHORS: 2020-02-06
• 00880304477315 - JUGGERKNOT SOFT ANCHORS: 2020-02-06
• 00880304508590 - JUGGERKNOT SOFT ANCHORS: 2020-02-06
• 00880304509627 - JUGGERKNOT SOFT ANCHORS: 2020-02-06
• 00880304511699 - JUGGERKNOT SOFT ANCHORS: 2020-02-06