TK2 ™SHORT BARREL 841540105

GUDID 00887868052880

Biomet Orthopedics, LLC

Hip internal fixation system

• Primary Device ID: 00887868052880
• NIH Device Record Key: 17e2513d-6fcb-49a0-b751-c425fccad893
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TK2 ™SHORT BARREL
• Version Model Number: 8415-40-105
• Catalog Number: 841540105
• 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	00887868052880 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111663

FDA Product Code

• JDW: PIN, FIXATION, THREADED

Sterilization

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

[00887868052880]

Moist Heat or Steam Sterilization

[00887868052880]

Moist Heat or Steam Sterilization

[00887868052880]

Moist Heat or Steam Sterilization

[00887868052880]

Moist Heat or Steam Sterilization

[00887868052880]

Moist Heat or Steam Sterilization

[00887868052880]

Moist Heat or Steam Sterilization

[00887868052880]

Moist Heat or Steam Sterilization

[00887868052880]

Moist Heat or Steam Sterilization

[00887868052880]

Moist Heat or Steam Sterilization

[00887868052880]

Moist Heat or Steam Sterilization

[00887868052880]

Moist Heat or Steam Sterilization

[00887868052880]

Moist Heat or Steam Sterilization

[00887868052880]

Moist Heat or Steam Sterilization

[00887868052880]

Moist Heat or Steam Sterilization

[00887868052880]

Moist Heat or Steam Sterilization

[00887868052880]

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 [TK2 ™SHORT BARREL]

• 00887868053139: 8415-50-106
• 00887868053122: 8415-50-105
• 00887868053115: 8415-50-104
• 00887868053016: 8415-45-106
• 00887868053009: 8415-45-105
• 00887868052996: 8415-45-104
• 00887868052897: 8415-40-106
• 00887868052880: 8415-40-105
• 00887868052873: 8415-40-104
• 00887868052866: 8415-40-103
• 00887868052859: 8415-40-102
• 00887868052750: 8415-35-106
• 00887868052743: 8415-35-105
• 00887868052736: 8415-35-104
• 00887868052729: 8415-35-103
• 00887868052712: 8415-35-102
• 00887868052613: 8415-30-106
• 00887868052606: 8415-30-105
• 00887868052590: 8415-30-104
• 00887868052583: 8415-30-103
• 00887868052576: 8415-30-102