A.L.P.S. ELBOW SYSTEM DISTAL HUMERAL POSTERIOR LATERAL PLATE - LEFT 131218803

GUDID 00887868013249

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: 00887868013249
• NIH Device Record Key: 53653a2f-7ffd-4603-9dd2-8b5b80c7b71d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: A.L.P.S. ELBOW SYSTEM DISTAL HUMERAL POSTERIOR LATERAL PLATE - LEFT
• Version Model Number: 1312-18-803
• Catalog Number: 131218803
• 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	00887868013249 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103408

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[00887868013249]

Moist Heat or Steam Sterilization

[00887868013249]

Moist Heat or Steam Sterilization

[00887868013249]

Moist Heat or Steam Sterilization

[00887868013249]

Moist Heat or Steam Sterilization

[00887868013249]

Moist Heat or Steam Sterilization

[00887868013249]

Moist Heat or Steam Sterilization

[00887868013249]

Moist Heat or Steam Sterilization

[00887868013249]

Moist Heat or Steam Sterilization

[00887868013249]

Moist Heat or Steam Sterilization

[00887868013249]

Moist Heat or Steam Sterilization

[00887868013249]

Moist Heat or Steam Sterilization

[00887868013249]

Moist Heat or Steam Sterilization

[00887868013249]

Moist Heat or Steam Sterilization

[00887868013249]

Moist Heat or Steam Sterilization

[00887868013249]

Moist Heat or Steam Sterilization

[00887868013249]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-14
• Device Publish Date: 2015-10-24

On-Brand Devices [A.L.P.S. ELBOW SYSTEM DISTAL HUMERAL POSTERIOR LATERAL PLATE - LEFT]

• 00887868013256: 1312-18-804
• 00887868013249: 1312-18-803
• 00887868013027: 1312-18-308