CANNULATED CORTICAL BONE SCREW 1437520

GUDID 00887868008634

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: 00887868008634
• NIH Device Record Key: 865303c1-2089-48c8-92a4-6e06b950dbd8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CANNULATED CORTICAL BONE SCREW
• Version Model Number: 14375-20
• Catalog Number: 1437520
• 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	00887868008634 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111663

FDA Product Code

• LXT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE

Sterilization

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

[00887868008634]

Moist Heat or Steam Sterilization

[00887868008634]

Moist Heat or Steam Sterilization

[00887868008634]

Moist Heat or Steam Sterilization

[00887868008634]

Moist Heat or Steam Sterilization

[00887868008634]

Moist Heat or Steam Sterilization

[00887868008634]

Moist Heat or Steam Sterilization

[00887868008634]

Moist Heat or Steam Sterilization

[00887868008634]

Moist Heat or Steam Sterilization

[00887868008634]

Moist Heat or Steam Sterilization

[00887868008634]

Moist Heat or Steam Sterilization

[00887868008634]

Moist Heat or Steam Sterilization

[00887868008634]

Moist Heat or Steam Sterilization

[00887868008634]

Moist Heat or Steam Sterilization

[00887868008634]

Moist Heat or Steam Sterilization

[00887868008634]

Moist Heat or Steam Sterilization

[00887868008634]

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 [CANNULATED CORTICAL BONE SCREW]

• 00887868008825: 14375-70
• 00887868008818: 14375-65
• 00887868008801: 14375-60
• 00887868008795: 14375-55
• 00887868008788: 14375-50
• 00887868008771: 14375-48
• 00887868008764: 14375-46
• 00887868008757: 14375-44
• 00887868008740: 14375-42
• 00887868008733: 14375-40
• 00887868008726: 14375-38
• 00887868008719: 14375-36
• 00887868008702: 14375-34
• 00887868008696: 14375-32
• 00887868008689: 14375-30
• 00887868008672: 14375-28
• 00887868008665: 14375-26
• 00887868008658: 14375-24
• 00887868008641: 14375-22
• 00887868008634: 14375-20
• 00887868008627: 14375-18
• 00887868008610: 14375-16
• 00887868008603: 14375-14
• 00887868008597: 14375-12
• 00887868008580: 14375-10
• 00887868007064: 14200-70
• 00887868007057: 14200-65
• 00887868007040: 14200-60
• 00887868007033: 14200-55
• 00887868007026: 14200-50
• 00887868007019: 14200-48
• 00887868007002: 14200-46
• 00887868006999: 14200-44
• 00887868006982: 14200-42
• 00887868006975: 14200-40
• 00887868006968: 14200-38
• 00887868006951: 14200-36
• 00887868006944: 14200-34
• 00887868006937: 14200-32
• 00887868006920: 14200-30
• 00887868006913: 14200-28
• 00887868006906: 14200-26
• 00887868006890: 14200-24
• 00887868006883: 14200-22
• 00887868006876: 14200-20