40MM THREAD CANNULATED CANCELLOUS SCREW 14197115

GUDID 00887868010187

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: 00887868010187
• NIH Device Record Key: e0f9c387-d61d-41df-85d7-1d99c724f5b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 40MM THREAD CANNULATED CANCELLOUS SCREW
• Version Model Number: 14197-115
• Catalog Number: 14197115
• 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	00887868010187 [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

[00887868010187]

Moist Heat or Steam Sterilization

[00887868010187]

Moist Heat or Steam Sterilization

[00887868010187]

Moist Heat or Steam Sterilization

[00887868010187]

Moist Heat or Steam Sterilization

[00887868010187]

Moist Heat or Steam Sterilization

[00887868010187]

Moist Heat or Steam Sterilization

[00887868010187]

Moist Heat or Steam Sterilization

[00887868010187]

Moist Heat or Steam Sterilization

[00887868010187]

Moist Heat or Steam Sterilization

[00887868010187]

Moist Heat or Steam Sterilization

[00887868010187]

Moist Heat or Steam Sterilization

[00887868010187]

Moist Heat or Steam Sterilization

[00887868010187]

Moist Heat or Steam Sterilization

[00887868010187]

Moist Heat or Steam Sterilization

[00887868010187]

Moist Heat or Steam Sterilization

[00887868010187]

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 [40MM THREAD CANNULATED CANCELLOUS SCREW]

• 00887868010316: 14197-180
• 00887868010309: 14197-175
• 00887868010293: 14197-170
• 00887868010286: 14197-165
• 00887868010279: 14197-160
• 00887868010262: 14197-155
• 00887868010217: 14197-130
• 00887868010200: 14197-125
• 00887868010194: 14197-120
• 00887868010187: 14197-115
• 00887868010170: 14197-110
• 00887868010163: 14197-105
• 00887868010156: 14197-100
• 00887868006869: 14197-95
• 00887868006852: 14197-90
• 00887868006845: 14197-85
• 00887868006838: 14197-80
• 00887868006821: 14197-75
• 00887868006814: 14197-70
• 00887868006807: 14197-65
• 00887868006791: 14197-60
• 00887868006784: 14197-55
• 00887868006777: 14197-50
• 00887868006760: 14197-45
• 00887868006753: 14197-40
• 00887868057526: 8515-65-120
• 00887868057519: 8515-65-115
• 00887868057502: 8515-65-110
• 00887868057496: 8515-65-105
• 00887868057489: 8515-65-100
• 00887868057472: 8515-65-095
• 00887868057465: 8515-65-090
• 00887868057458: 8515-65-085
• 00887868057441: 8515-65-080
• 00887868057434: 8515-65-075
• 00887868057427: 8515-65-070
• 00887868057410: 8515-65-065
• 00887868057403: 8515-65-060
• 00887868057397: 8515-65-055
• 00887868057380: 8515-65-050
• 00887868057373: 8515-65-045
• 00887868057366: 8515-65-040