CORTICAL SCREW FULL THREAD 815745024

GUDID 00887868042355

Biomet Orthopedics, LLC

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

• Primary Device ID: 00887868042355
• NIH Device Record Key: 09c16804-9579-4b9d-a6d6-ac0f1ae52c5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CORTICAL SCREW FULL THREAD
• Version Model Number: 8157-45-024
• Catalog Number: 815745024
• 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
• 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	00887868042355 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060969

FDA Product Code

• HRS: PLATE, FIXATION, BONE

Sterilization

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

[00887868042355]

Moist Heat or Steam Sterilization

[00887868042355]

Moist Heat or Steam Sterilization

[00887868042355]

Moist Heat or Steam Sterilization

[00887868042355]

Moist Heat or Steam Sterilization

[00887868042355]

Moist Heat or Steam Sterilization

[00887868042355]

Moist Heat or Steam Sterilization

[00887868042355]

Moist Heat or Steam Sterilization

[00887868042355]

Moist Heat or Steam Sterilization

[00887868042355]

Moist Heat or Steam Sterilization

[00887868042355]

Moist Heat or Steam Sterilization

[00887868042355]

Moist Heat or Steam Sterilization

[00887868042355]

Moist Heat or Steam Sterilization

[00887868042355]

Moist Heat or Steam Sterilization

[00887868042355]

Moist Heat or Steam Sterilization

[00887868042355]

Moist Heat or Steam Sterilization

[00887868042355]

Moist Heat or Steam Sterilization

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 [CORTICAL SCREW FULL THREAD]

• 00887868042638: 8157-45-110
• 00887868042621: 8157-45-105
• 00887868042614: 8157-45-100
• 00887868042607: 8157-45-095
• 00887868042591: 8157-45-090
• 00887868042584: 8157-45-085
• 00887868042577: 8157-45-080
• 00887868042560: 8157-45-075
• 00887868042553: 8157-45-070
• 00887868042546: 8157-45-065
• 00887868042539: 8157-45-060
• 00887868042522: 8157-45-058
• 00887868042515: 8157-45-056
• 00887868042508: 8157-45-054
• 00887868042492: 8157-45-052
• 00887868042485: 8157-45-050
• 00887868042478: 8157-45-048
• 00887868042461: 8157-45-046
• 00887868042454: 8157-45-044
• 00887868042447: 8157-45-042
• 00887868042430: 8157-45-040
• 00887868042423: 8157-45-038
• 00887868042416: 8157-45-036
• 00887868042409: 8157-45-034
• 00887868042393: 8157-45-032
• 00887868042386: 8157-45-030
• 00887868042379: 8157-45-028
• 00887868042362: 8157-45-026
• 00887868042355: 8157-45-024
• 00887868042348: 8157-45-022
• 00887868042331: 8157-45-020
• 00887868042324: 8157-45-018
• 00887868042317: 8157-45-016
• 00887868042300: 8157-45-014
• 00887868042294: 8157-45-012
• 00887868042287: 8157-45-010