ALPS MESH LOCKING CALCANEAL PLATE 110018292

GUDID 00887868130847

Biomet Orthopedics, LLC

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 00887868130847
• NIH Device Record Key: 8ed1f90e-77d9-46f4-ab4b-7c4ff4b38fb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALPS MESH LOCKING CALCANEAL PLATE
• Version Model Number: 110018292
• Catalog Number: 110018292
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868130847 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132898

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[00887868130847]

Moist Heat or Steam Sterilization

[00887868130847]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-01-21
• Device Publish Date: 2018-12-19

On-Brand Devices [ALPS MESH LOCKING CALCANEAL PLATE]

• 00887868130892: 110018297
• 00887868130885: 110018296
• 00887868130878: 110018295
• 00887868130861: 110018294
• 00887868130854: 110018293
• 00887868130847: 110018292