A.L.P.S.PROXIMAL TIBIA LOCKED PLATE, RIGHT LARGE 816235615

GUDID 00887868045066

Biomet Orthopedics, LLC

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

• Primary Device ID: 00887868045066
• NIH Device Record Key: 87ea79ab-20cd-452d-82c7-e42e18c95075
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: A.L.P.S.PROXIMAL TIBIA LOCKED PLATE, RIGHT LARGE
• Version Model Number: 8162-35-615
• Catalog Number: 816235615
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• 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	00887868045066 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090877

FDA Product Code

• JDW: PIN, FIXATION, THREADED

Sterilization

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

[00887868045066]

Moist Heat or Steam Sterilization

[00887868045066]

Moist Heat or Steam Sterilization

[00887868045066]

Moist Heat or Steam Sterilization

[00887868045066]

Moist Heat or Steam Sterilization

[00887868045066]

Moist Heat or Steam Sterilization

[00887868045066]

Moist Heat or Steam Sterilization

[00887868045066]

Moist Heat or Steam Sterilization

[00887868045066]

Moist Heat or Steam Sterilization

[00887868045066]

Moist Heat or Steam Sterilization

[00887868045066]

Moist Heat or Steam Sterilization

[00887868045066]

Moist Heat or Steam Sterilization

[00887868045066]

Moist Heat or Steam Sterilization

[00887868045066]

Moist Heat or Steam Sterilization

[00887868045066]

Moist Heat or Steam Sterilization

[00887868045066]

Moist Heat or Steam Sterilization

[00887868045066]

Moist Heat or Steam Sterilization

[00887868045066]

Moist Heat or Steam Sterilization

[00887868045066]

Moist Heat or Steam Sterilization

[00887868045066]

Moist Heat or Steam Sterilization

[00887868045066]

Moist Heat or Steam Sterilization

[00887868045066]

Moist Heat or Steam Sterilization

[00887868045066]

Moist Heat or Steam Sterilization

[00887868045066]

Moist Heat or Steam Sterilization

[00887868045066]

Moist Heat or Steam Sterilization

[00887868045066]

Moist Heat or Steam Sterilization

[00887868045066]

Moist Heat or Steam Sterilization

[00887868045066]

Moist Heat or Steam Sterilization

[00887868045066]

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 [A.L.P.S.PROXIMAL TIBIA LOCKED PLATE, RIGHT LARGE]

• 00887868045066: 8162-35-615
• 00887868045059: 8162-35-613
• 00887868045042: 8162-35-611
• 00887868045035: 8162-35-609
• 00887868045028: 8162-35-607
• 00887868045011: 8162-35-605
• 00887868045004: 8162-35-603