FIBULA ANATOMIC LOCKING PLATE, LEFT 816206004

GUDID 00887868044519

Biomet Orthopedics, LLC

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 00887868044519
• NIH Device Record Key: 62a0c5ae-1a06-4842-8e5e-221a8382c5fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FIBULA ANATOMIC LOCKING PLATE, LEFT
• Version Model Number: 8162-06-004
• Catalog Number: 816206004
• 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

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 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	00887868044519 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083843

FDA Product Code

• JDW: PIN, FIXATION, THREADED

Sterilization

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

[00887868044519]

Moist Heat or Steam Sterilization

[00887868044519]

Moist Heat or Steam Sterilization

[00887868044519]

Moist Heat or Steam Sterilization

[00887868044519]

Moist Heat or Steam Sterilization

[00887868044519]

Moist Heat or Steam Sterilization

[00887868044519]

Moist Heat or Steam Sterilization

[00887868044519]

Moist Heat or Steam Sterilization

[00887868044519]

Moist Heat or Steam Sterilization

[00887868044519]

Moist Heat or Steam Sterilization

[00887868044519]

Moist Heat or Steam Sterilization

[00887868044519]

Moist Heat or Steam Sterilization

[00887868044519]

Moist Heat or Steam Sterilization

[00887868044519]

Moist Heat or Steam Sterilization

[00887868044519]

Moist Heat or Steam Sterilization

[00887868044519]

Moist Heat or Steam Sterilization

[00887868044519]

Moist Heat or Steam Sterilization

[00887868044519]

Moist Heat or Steam Sterilization

[00887868044519]

Moist Heat or Steam Sterilization

[00887868044519]

Moist Heat or Steam Sterilization

[00887868044519]

Moist Heat or Steam Sterilization

[00887868044519]

Moist Heat or Steam Sterilization

[00887868044519]

Moist Heat or Steam Sterilization

[00887868044519]

Moist Heat or Steam Sterilization

[00887868044519]

Moist Heat or Steam Sterilization

[00887868044519]

Moist Heat or Steam Sterilization

[00887868044519]

Moist Heat or Steam Sterilization

[00887868044519]

Moist Heat or Steam Sterilization

[00887868044519]

Moist Heat or Steam Sterilization

[00887868044519]

Moist Heat or Steam Sterilization

[00887868044519]

Moist Heat or Steam Sterilization

[00887868044519]

Moist Heat or Steam Sterilization

[00887868044519]

Moist Heat or Steam Sterilization

[00887868044519]

Moist Heat or Steam Sterilization

[00887868044519]

Moist Heat or Steam Sterilization

[00887868044519]

Moist Heat or Steam Sterilization

[00887868044519]

Moist Heat or Steam Sterilization

[00887868044519]

Moist Heat or Steam Sterilization

[00887868044519]

Moist Heat or Steam Sterilization

[00887868044519]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-24
• Device Publish Date: 2015-10-24

On-Brand Devices [FIBULA ANATOMIC LOCKING PLATE, LEFT]

• 00887868044540: 8162-06-010
• 00887868044533: 8162-06-008
• 00887868044526: 8162-06-006
• 00887868044519: 8162-06-004
• 00887868044502: 8162-06-003