FIBULA COMPOSITE LOCKING PLATE 816204010

GUDID 00887868044472

Biomet Orthopedics, LLC

Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 00887868044472
• NIH Device Record Key: 5e4a630f-9a6f-4515-b016-904c10904db4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FIBULA COMPOSITE LOCKING PLATE
• Version Model Number: 8162-04-010
• Catalog Number: 816204010
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	00887868044472 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083843

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[00887868044472]

Moist Heat or Steam Sterilization

[00887868044472]

Moist Heat or Steam Sterilization

[00887868044472]

Moist Heat or Steam Sterilization

[00887868044472]

Moist Heat or Steam Sterilization

[00887868044472]

Moist Heat or Steam Sterilization

[00887868044472]

Moist Heat or Steam Sterilization

[00887868044472]

Moist Heat or Steam Sterilization

[00887868044472]

Moist Heat or Steam Sterilization

[00887868044472]

Moist Heat or Steam Sterilization

[00887868044472]

Moist Heat or Steam Sterilization

[00887868044472]

Moist Heat or Steam Sterilization

[00887868044472]

Moist Heat or Steam Sterilization

[00887868044472]

Moist Heat or Steam Sterilization

[00887868044472]

Moist Heat or Steam Sterilization

[00887868044472]

Moist Heat or Steam Sterilization

[00887868044472]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-15
• Device Publish Date: 2017-03-17

On-Brand Devices [FIBULA COMPOSITE LOCKING PLATE]

• 00887868044496: 8162-04-014
• 00887868044489: 8162-04-012
• 00887868044472: 8162-04-010
• 00887868044465: 8162-04-008
• 00887868044458: 8162-04-007
• 00887868044441: 8162-04-006