MULTI-AXIAL CORRECTION SYSTEM 15255

GUDID 00880304486294

Biomet Orthopedics, LLC

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

• Primary Device ID: 00880304486294
• NIH Device Record Key: 8fbf8d5e-7cd3-4747-a102-d031e56dd2e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MULTI-AXIAL CORRECTION SYSTEM
• Version Model Number: 15255
• Catalog Number: 15255
• 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

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 Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304486294 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031645

FDA Product Code

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

Sterilization

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

[00880304486294]

Moist Heat or Steam Sterilization

[00880304486294]

Moist Heat or Steam Sterilization

[00880304486294]

Moist Heat or Steam Sterilization

[00880304486294]

Moist Heat or Steam Sterilization

[00880304486294]

Moist Heat or Steam Sterilization

[00880304486294]

Moist Heat or Steam Sterilization

[00880304486294]

Moist Heat or Steam Sterilization

[00880304486294]

Moist Heat or Steam Sterilization

[00880304486294]

Moist Heat or Steam Sterilization

[00880304486294]

Moist Heat or Steam Sterilization

[00880304486294]

Moist Heat or Steam Sterilization

[00880304486294]

Moist Heat or Steam Sterilization

[00880304486294]

Moist Heat or Steam Sterilization

[00880304486294]

Moist Heat or Steam Sterilization

[00880304486294]

Moist Heat or Steam Sterilization

[00880304486294]

Moist Heat or Steam Sterilization

[00880304486294]

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 [MULTI-AXIAL CORRECTION SYSTEM]

• 00880304552241: 13050
• 00880304510005: 13020
• 00880304492752: 15219
• 00880304491793: 13035
• 00880304491731: 13080
• 00880304491700: 13040
• 00880304490734: 15210
• 00880304489530: 15220
• 00880304487406: 15270
• 00880304486294: 15255
• 00888480190516: 15305
• 00888480190486: 15290
• 00888480190455: 15277
• 00888480190431: 15272
• 00888480190370: 15260
• 00888480190356: 15250
• 00888480190325: 15240
• 00888480152996: 13005
• 00887868093067: 14-415355
• 00887868093050: 14-415286
• 00888480444374: 14-415345