DYNAFIX VS OSTEOTOMY SYSTEM 10075P

GUDID 00880304486966

Biomet Orthopedics, LLC

Orthopaedic fixation plate, non-bioabsorbable, sterile

• Primary Device ID: 00880304486966
• NIH Device Record Key: 13c8b516-2f8a-4d6d-a7d3-1f4e540b18d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DYNAFIX VS OSTEOTOMY SYSTEM
• Version Model Number: 10075P
• Catalog Number: 10075P
• 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

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 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	00880304486966 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010551

FDA Product Code

• NDF: PLATE, FIXATION, BONE, NON-SPINAL, METALLIC

Sterilization

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

[00880304486966]

Moist Heat or Steam Sterilization

[00880304486966]

Moist Heat or Steam Sterilization

[00880304486966]

Moist Heat or Steam Sterilization

[00880304486966]

Moist Heat or Steam Sterilization

[00880304486966]

Moist Heat or Steam Sterilization

[00880304486966]

Moist Heat or Steam Sterilization

[00880304486966]

Moist Heat or Steam Sterilization

[00880304486966]

Moist Heat or Steam Sterilization

[00880304486966]

Moist Heat or Steam Sterilization

[00880304486966]

Moist Heat or Steam Sterilization

[00880304486966]

Moist Heat or Steam Sterilization

[00880304486966]

Moist Heat or Steam Sterilization

[00880304486966]

Moist Heat or Steam Sterilization

[00880304486966]

Moist Heat or Steam Sterilization

[00880304486966]

Moist Heat or Steam Sterilization

[00880304486966]

Moist Heat or Steam Sterilization

[00880304486966]

Moist Heat or Steam Sterilization

[00880304486966]

Moist Heat or Steam Sterilization

[00880304486966]

Moist Heat or Steam Sterilization

[00880304486966]

Moist Heat or Steam Sterilization

[00880304486966]

Moist Heat or Steam Sterilization

[00880304486966]

Moist Heat or Steam Sterilization

[00880304486966]

Moist Heat or Steam Sterilization

[00880304486966]

Moist Heat or Steam Sterilization

[00880304486966]

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 [DYNAFIX VS OSTEOTOMY SYSTEM]

• 00880304552265: 12200P
• 00880304532144: 11050P
• 00880304529205: 10050P
• 00880304506770: 11062P
• 00880304505612: 10125P
• 00880304504851: 12175P
• 00880304498044: 10062P
• 00880304495067: 12150P
• 00880304492905: 13150P
• 00880304491908: 10112P
• 00880304490840: 11075P
• 00880304487482: 11100P
• 00880304486966: 10075P
• 00880304486690: 10088P
• 00880304486621: 11088P
• 00880304486089: 11125P
• 00880304485679: 10100P
• 00880304485600: 11112P
• 00888480188117: 14085P
• 00888480187790: 14026P
• 00888480187776: 14024P
• 00888480153511: 13225P
• 00888480153498: 13200P
• 00888480153450: 13175P
• 00887868151378: 14030P
• 00887868090196: 14090P
• 00887868090172: 14080P
• 00887868090165: 14075P
• 00887868090158: 14070P
• 00887868090141: 14065P
• 00887868090134: 14060P
• 00887868090127: 14055P
• 00887868090110: 14050P
• 00887868090103: 14045P
• 00887868090097: 14044P
• 00887868090080: 14042P
• 00887868090073: 14040P
• 00887868090066: 14038P
• 00887868090059: 14036P
• 00887868090042: 14034P
• 00887868090035: 14032P
• 00887868090011: 14028P
• 00887868089916: 12225P