TK2 ™KEYLESS LAG SCREW 801302080

GUDID 00887868033384

Biomet Orthopedics, LLC

Hip internal fixation system

• Primary Device ID: 00887868033384
• NIH Device Record Key: d55278a5-474c-41f1-9c37-e4397f53746e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TK2 ™KEYLESS LAG SCREW
• Version Model Number: 8013-02-080
• Catalog Number: 801302080
• 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: true
• 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	00887868033384 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111663

FDA Product Code

• JDW: PIN, FIXATION, THREADED

Sterilization

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

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 ™KEYLESS LAG SCREW]

• 00887868035630: 8113-02-140
• 00887868035623: 8113-02-130
• 00887868035616: 8113-02-120
• 00887868035609: 8113-02-110
• 00887868035593: 8113-02-100
• 00887868035586: 8113-02-090
• 00887868035579: 8113-02-080
• 00887868035562: 8113-02-070
• 00887868035555: 8113-02-060
• 00887868035548: 8113-02-050
• 00887868033476: 8013-02-140
• 00887868033469: 8013-02-130
• 00887868033452: 8013-02-120
• 00887868033445: 8013-02-110
• 00887868033438: 8013-02-105
• 00887868033421: 8013-02-100
• 00887868033414: 8013-02-095
• 00887868033407: 8013-02-090
• 00887868033391: 8013-02-085
• 00887868033384: 8013-02-080
• 00887868033377: 8013-02-075
• 00887868033360: 8013-02-070
• 00887868033353: 8013-02-060
• 00887868033346: 8013-02-050