AFFIXUS®CORTICAL BONE SCREW 814550022

GUDID 00887868039416

Biomet Orthopedics, LLC

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00887868039416
• NIH Device Record Key: fc6a8d8c-ca98-4d5e-932b-cc7d1651cc73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AFFIXUS®CORTICAL BONE SCREW
• Version Model Number: 8145-50-022
• Catalog Number: 814550022
• 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	00887868039416 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100238

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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 [AFFIXUS®CORTICAL BONE SCREW]

• 00887868039645: 8145-50-080
• 00887868039638: 8145-50-075
• 00887868039621: 8145-50-070
• 00887868039614: 8145-50-065
• 00887868039607: 8145-50-060
• 00887868039591: 8145-50-058
• 00887868039584: 8145-50-056
• 00887868039577: 8145-50-054
• 00887868039560: 8145-50-052
• 00887868039553: 8145-50-050
• 00887868039546: 8145-50-048
• 00887868039539: 8145-50-046
• 00887868039522: 8145-50-044
• 00887868039515: 8145-50-042
• 00887868039508: 8145-50-040
• 00887868039492: 8145-50-038
• 00887868039485: 8145-50-036
• 00887868039478: 8145-50-034
• 00887868039461: 8145-50-032
• 00887868039454: 8145-50-030
• 00887868039447: 8145-50-028
• 00887868039430: 8145-50-026
• 00887868039423: 8145-50-024
• 00887868039416: 8145-50-022
• 00887868039409: 8145-50-020