A.L.P.S. FOOT LOCKING CALCANEUS PLATE, LARGE - LEFT 816208003

GUDID 00887868044649

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: 00887868044649
• NIH Device Record Key: 9b7e73e1-51cb-4ea8-86ca-5a5424b3ca65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: A.L.P.S. FOOT LOCKING CALCANEUS PLATE, LARGE - LEFT
• Version Model Number: 8162-08-003
• Catalog Number: 816208003
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00887868044649 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093474

FDA Product Code

• HRS: PLATE, FIXATION, BONE

Sterilization

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

[00887868044649]

Moist Heat or Steam Sterilization

[00887868044649]

Moist Heat or Steam Sterilization

[00887868044649]

Moist Heat or Steam Sterilization

[00887868044649]

Moist Heat or Steam Sterilization

[00887868044649]

Moist Heat or Steam Sterilization

[00887868044649]

Moist Heat or Steam Sterilization

[00887868044649]

Moist Heat or Steam Sterilization

[00887868044649]

Moist Heat or Steam Sterilization

[00887868044649]

Moist Heat or Steam Sterilization

[00887868044649]

Moist Heat or Steam Sterilization

[00887868044649]

Moist Heat or Steam Sterilization

[00887868044649]

Moist Heat or Steam Sterilization

[00887868044649]

Moist Heat or Steam Sterilization

[00887868044649]

Moist Heat or Steam Sterilization

[00887868044649]

Moist Heat or Steam Sterilization

[00887868044649]

Moist Heat or Steam Sterilization

[00887868044649]

Moist Heat or Steam Sterilization

[00887868044649]

Moist Heat or Steam Sterilization

[00887868044649]

Moist Heat or Steam Sterilization

[00887868044649]

Moist Heat or Steam Sterilization

[00887868044649]

Moist Heat or Steam Sterilization

[00887868044649]

Moist Heat or Steam Sterilization

[00887868044649]

Moist Heat or Steam Sterilization

[00887868044649]

Moist Heat or Steam Sterilization

[00887868044649]

Moist Heat or Steam Sterilization

[00887868044649]

Moist Heat or Steam Sterilization

[00887868044649]

Moist Heat or Steam Sterilization

[00887868044649]

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. FOOT LOCKING CALCANEUS PLATE, LARGE - LEFT]

• 00887868046933: 8166-08-003
• 00887868044649: 8162-08-003