FULLY THREADED CORTICAL SCREW 855745036

GUDID 00887868060038

Biomet Orthopedics, LLC

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

• Primary Device ID: 00887868060038
• NIH Device Record Key: f618e78d-20be-412c-8d19-440f8b328fb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FULLY THREADED CORTICAL SCREW
• Version Model Number: 8557-45-036
• Catalog Number: 855745036
• 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
• 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 Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868060038 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111663

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 [FULLY THREADED CORTICAL SCREW]

• 00887868060175: 8557-45-070
• 00887868060168: 8557-45-065
• 00887868060151: 8557-45-060
• 00887868060144: 8557-45-058
• 00887868060137: 8557-45-056
• 00887868060120: 8557-45-054
• 00887868060113: 8557-45-052
• 00887868060106: 8557-45-050
• 00887868060090: 8557-45-048
• 00887868060083: 8557-45-046
• 00887868060076: 8557-45-044
• 00887868060069: 8557-45-042
• 00887868060052: 8557-45-040
• 00887868060045: 8557-45-038
• 00887868060038: 8557-45-036
• 00887868060021: 8557-45-034
• 00887868060014: 8557-45-032
• 00887868060007: 8557-45-030
• 00887868059995: 8557-45-028
• 00887868059988: 8557-45-026
• 00887868059971: 8557-45-024
• 00887868059964: 8557-45-022
• 00887868059957: 8557-45-020
• 00887868059940: 8557-45-018
• 00887868059933: 8557-45-016
• 00887868059926: 8557-45-014
• 00887868057885: 8540-27-038
• 00887868057878: 8540-27-036
• 00887868057861: 8540-27-034
• 00887868057854: 8540-27-032
• 00887868057847: 8540-27-030
• 00887868057830: 8540-27-028
• 00887868057823: 8540-27-026
• 00887868057816: 8540-27-024
• 00887868057809: 8540-27-022
• 00887868057793: 8540-27-020
• 00887868057786: 8540-27-018
• 00887868057779: 8540-27-016
• 00887868057762: 8540-27-014
• 00887868057755: 8540-27-012
• 00887868057748: 8540-27-010
• 00887868447907: 8557-45-070
• 00887868447891: 8557-45-065
• 00887868447884: 8557-45-060
• 00887868447877: 8557-45-058
• 00887868447860: 8557-45-056
• 00887868447853: 8557-45-054
• 00887868447846: 8557-45-052
• 00887868447839: 8557-45-050
• 00887868447822: 8557-45-048