FRS™CANNULATED SCREW 852030016

GUDID 00887868057632

Biomet Orthopedics, LLC

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00887868057632
• NIH Device Record Key: c9035246-cea8-44ff-b630-f655f8ccbada
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FRS™CANNULATED SCREW
• Version Model Number: 8520-30-016
• Catalog Number: 852030016
• 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: 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

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868057632 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062352

FDA Product Code

• HWC: Screw, fixation, bone

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 [FRS™CANNULATED SCREW]

• 00887868057724: 8520-30-034
• 00887868057717: 8520-30-032
• 00887868057700: 8520-30-030
• 00887868057694: 8520-30-028
• 00887868057687: 8520-30-026
• 00887868057670: 8520-30-024
• 00887868057663: 8520-30-022
• 00887868057656: 8520-30-020
• 00887868057649: 8520-30-018
• 00887868057632: 8520-30-016
• 00887868057625: 8520-30-014
• 00887868057618: 8520-25-026
• 00887868057601: 8520-25-024
• 00887868057595: 8520-25-022
• 00887868057588: 8520-25-020
• 00887868057571: 8520-25-018
• 00887868057564: 8520-25-016
• 00887868057557: 8520-25-014
• 00887868057540: 8520-25-012
• 00887868057533: 8520-25-010