12 HOLE LOCKING DISTAL TIBIA ANTEROLATERAL PLATE 816203012

GUDID 00887868551413

Biomet Orthopedics, LLC

Orthopaedic fixation plate, non-bioabsorbable, sterile

• Primary Device ID: 00887868551413
• NIH Device Record Key: 8f04a874-7246-47c9-8588-06e3d1db524b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 12 HOLE LOCKING DISTAL TIBIA ANTEROLATERAL PLATE
• Version Model Number: 8162-03-012
• Catalog Number: 816203012
• 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
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868551413 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072832

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

[00887868551413]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-28
• Device Publish Date: 2022-02-18

On-Brand Devices [12 HOLE LOCKING DISTAL TIBIA ANTEROLATERAL PLATE]

• 00887868551413: 8162-03-012
• 00887868551376: 8162-02-012