"2.0MM SYSTEM" 91-2023

GUDID 00841036053468

BIOMET MICROFIXATION, INC

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00841036053468
• NIH Device Record Key: 322c7bfd-a00d-418f-9be1-839fc2d107c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: "2.0MM SYSTEM"
• Version Model Number: 91-2023
• Catalog Number: 91-2023
• Company DUNS: 046189866
• Company Name: BIOMET MICROFIXATION, INC
• 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(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841036053468 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121589

FDA Product Code

• JEY: PLATE, BONE

Sterilization

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

[00841036053468]

Moist Heat or Steam Sterilization

[00841036053468]

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: 2015-10-11

On-Brand Devices ["2.0MM SYSTEM"]

• 00841036053499: 91-2307
• 00841036053482: 91-2305
• 00841036053475: 91-2027
• 00841036053468: 91-2023
• 00841036053383: 91-2007
• 00841036053376: 91-2005