XS Multi-Axial Correction System 14-415360

GUDID 00880304591905

Biomet Orthopedics, LLC

External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use

• Primary Device ID: 00880304591905
• NIH Device Record Key: c6573d58-e711-4b19-b87b-44e46599fb36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XS Multi-Axial Correction System
• Version Model Number: 14-415360
• Catalog Number: 14-415360
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00880304591905 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102843

FDA Product Code

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

Sterilization

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

[00880304591905]

Moist Heat or Steam Sterilization

[00880304591905]

Moist Heat or Steam Sterilization

[00880304591905]

Moist Heat or Steam Sterilization

[00880304591905]

Moist Heat or Steam Sterilization

[00880304591905]

Moist Heat or Steam Sterilization

[00880304591905]

Moist Heat or Steam Sterilization

[00880304591905]

Moist Heat or Steam Sterilization

[00880304591905]

Moist Heat or Steam Sterilization

[00880304591905]

Moist Heat or Steam Sterilization

[00880304591905]

Moist Heat or Steam Sterilization

[00880304591905]

Moist Heat or Steam Sterilization

[00880304591905]

Moist Heat or Steam Sterilization

[00880304591905]

Moist Heat or Steam Sterilization

[00880304591905]

Moist Heat or Steam Sterilization

[00880304591905]

Moist Heat or Steam Sterilization

[00880304591905]

Moist Heat or Steam Sterilization

[00880304591905]

Moist Heat or Steam Sterilization

[00880304591905]

Moist Heat or Steam Sterilization

[00880304591905]

Moist Heat or Steam Sterilization

[00880304591905]

Moist Heat or Steam Sterilization

[00880304591905]

Moist Heat or Steam Sterilization

[00880304591905]

Moist Heat or Steam Sterilization

[00880304591905]

Moist Heat or Steam Sterilization

[00880304591905]

Moist Heat or Steam Sterilization

[00880304591905]

Moist Heat or Steam Sterilization

[00880304591905]

Moist Heat or Steam Sterilization

[00880304591905]

Moist Heat or Steam Sterilization

[00880304591905]

Moist Heat or Steam Sterilization

[00880304591905]

Moist Heat or Steam Sterilization

[00880304591905]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-11
• Device Publish Date: 2020-08-03

On-Brand Devices [XS Multi-Axial Correction System]

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• 00880304533769: 15244
• 00880304532427: 15285
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• 00888480190448: 15275
• 00888480190349: 15245
• 00888480190318: 15230
• 00888480153221: 13115
• 00888480153214: 13110
• 00888480153207: 13105
• 00880304591905: 14-415360