VERSATILE SCREW SYSTEM 348629

GUDID 00880304419902

Biomet Orthopedics, LLC

Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable Orthopaedic fixation plate, bioabsorbable

• Primary Device ID: 00880304419902
• NIH Device Record Key: 267eb018-6208-46d6-8987-ec28cd0b57db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VERSATILE SCREW SYSTEM
• Version Model Number: 348629
• Catalog Number: 348629
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: true
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	00880304419902 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011237

FDA Product Code

• MAI: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Sterilization

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

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 [VERSATILE SCREW SYSTEM]

• 00880304419933: 348643
• 00880304419902: 348629