CORTICAL LOCK SCREW 131227126

GUDID 00880304532991

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 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: 00880304532991
• NIH Device Record Key: bfc5498f-4aaf-478f-8c5a-b83815d50cdd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CORTICAL LOCK SCREW
• Version Model Number: 1312-27-126
• Catalog Number: 131227126
• 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
• 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 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	00880304532991 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112345

FDA Product Code

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

Sterilization

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

[00880304532991]

Moist Heat or Steam Sterilization

[00880304532991]

Moist Heat or Steam Sterilization

[00880304532991]

Moist Heat or Steam Sterilization

[00880304532991]

Moist Heat or Steam Sterilization

[00880304532991]

Moist Heat or Steam Sterilization

[00880304532991]

Moist Heat or Steam Sterilization

[00880304532991]

Moist Heat or Steam Sterilization

[00880304532991]

Moist Heat or Steam Sterilization

[00880304532991]

Moist Heat or Steam Sterilization

[00880304532991]

Moist Heat or Steam Sterilization

[00880304532991]

Moist Heat or Steam Sterilization

[00880304532991]

Moist Heat or Steam Sterilization

[00880304532991]

Moist Heat or Steam Sterilization

[00880304532991]

Moist Heat or Steam Sterilization

[00880304532991]

Moist Heat or Steam Sterilization

[00880304532991]

Moist Heat or Steam Sterilization

[00880304532991]

Moist Heat or Steam Sterilization

[00880304532991]

Moist Heat or Steam Sterilization

[00880304532991]

Moist Heat or Steam Sterilization

[00880304532991]

Moist Heat or Steam Sterilization

[00880304532991]

Moist Heat or Steam Sterilization

[00880304532991]

Moist Heat or Steam Sterilization

[00880304532991]

Moist Heat or Steam Sterilization

[00880304532991]

Moist Heat or Steam Sterilization

[00880304532991]

Moist Heat or Steam Sterilization

[00880304532991]

Moist Heat or Steam Sterilization

[00880304532991]

Moist Heat or Steam Sterilization

[00880304532991]

Moist Heat or Steam Sterilization

[00880304532991]

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 LOCK SCREW]

• 00880304533011: 1312-27-130
• 00880304533004: 1312-27-128
• 00880304532991: 1312-27-126
• 00880304532984: 1312-27-124
• 00880304532977: 1312-27-122
• 00880304532960: 1312-27-120
• 00880304532953: 131227118
• 00880304532946: 131227116
• 00880304532939: 1312-27-115
• 00880304532922: 131227114
• 00880304532915: 1312-27-113
• 00880304532908: 131227112
• 00880304532892: 1312-27-111
• 00880304532885: 131227110
• 00880304532878: 1312-27-109
• 00880304532861: 1312-27-108
• 00887868545009: 131227130
• 00887868544996: 131227128
• 00887868544989: 131227126
• 00887868544972: 131227124
• 00887868544965: 131227122
• 00887868544958: 131227120
• 00887868544941: 131227118
• 00887868544934: 131227116
• 00887868544927: 131227115
• 00887868544910: 131227114
• 00887868544903: 131227113
• 00887868544897: 131227112
• 00887868544880: 131227111
• 00887868544873: 131227110
• 00887868544866: 131227109
• 00887868544859: 131227108