X FIX DYNAFIX SYSTEM 13150

GUDID 00880304509986

Biomet Orthopedics, LLC

External orthopaedic fixation system, single-use, non-sterile Medullary canal orthopaedic reamer, rigid Medullary canal orthopaedic reamer, rigid Medullary canal orthopaedic reamer, rigid Medullary canal orthopaedic reamer, rigid Medullary canal orthopaedic reamer, rigid Medullary canal orthopaedic reamer, rigid Medullary canal orthopaedic reamer, rigid Medullary canal orthopaedic reamer, rigid Medullary canal orthopaedic reamer, rigid Medullary canal orthopaedic reamer, rigid Medullary canal orthopaedic reamer, rigid Medullary canal orthopaedic reamer, rigid Medullary canal orthopaedic reamer, rigid Medullary canal orthopaedic reamer, rigid

• Primary Device ID: 00880304509986
• NIH Device Record Key: 0ea617d7-cb6d-443b-819e-2e3dcd8b0641
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X FIX DYNAFIX SYSTEM
• Version Model Number: 13150
• Catalog Number: 13150
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	00880304509986 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081244
• Premarket Notification: K953406

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

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

[00880304509986]

Moist Heat or Steam Sterilization

[00880304509986]

Moist Heat or Steam Sterilization

[00880304509986]

Moist Heat or Steam Sterilization

[00880304509986]

Moist Heat or Steam Sterilization

[00880304509986]

Moist Heat or Steam Sterilization

[00880304509986]

Moist Heat or Steam Sterilization

[00880304509986]

Moist Heat or Steam Sterilization

[00880304509986]

Moist Heat or Steam Sterilization

[00880304509986]

Moist Heat or Steam Sterilization

[00880304509986]

Moist Heat or Steam Sterilization

[00880304509986]

Moist Heat or Steam Sterilization

[00880304509986]

Moist Heat or Steam Sterilization

[00880304509986]

Moist Heat or Steam Sterilization

[00880304509986]

Moist Heat or Steam Sterilization

[00880304509986]

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: 2015-10-24

On-Brand Devices [X FIX DYNAFIX SYSTEM]

• 00880304529267: 13120
• 00880304529199: 13130
• 00880304509986: 13150
• 00880304506008: 13155
• 00880304505162: 13125
• 00880304491762: 13135
• 00880304491656: 13165