TK2 ™KEYED LAG SCREW 801301100

GUDID 00887868033285

Biomet Orthopedics, LLC

Hip internal fixation system

• Primary Device ID: 00887868033285
• NIH Device Record Key: e396d60f-8d29-4704-836d-93847b2dbae4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TK2 ™KEYED LAG SCREW
• Version Model Number: 8013-01-100
• Catalog Number: 801301100
• 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	00887868033285 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111663

FDA Product Code

• HRS: PLATE, FIXATION, BONE

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 ™KEYED LAG SCREW]

• 00887868035531: 8113-01-140
• 00887868035524: 8113-01-130
• 00887868035517: 8113-01-120
• 00887868035500: 8113-01-110
• 00887868035494: 8113-01-100
• 00887868035487: 8113-01-090
• 00887868035470: 8113-01-080
• 00887868035463: 8113-01-070
• 00887868035456: 8113-01-060
• 00887868035449: 8113-01-050
• 00887868033339: 8013-01-140
• 00887868033322: 8013-01-130
• 00887868033315: 8013-01-120
• 00887868033308: 8013-01-110
• 00887868033292: 8013-01-105
• 00887868033285: 8013-01-100
• 00887868033278: 8013-01-095
• 00887868033261: 8013-01-090
• 00887868033254: 8013-01-085
• 00887868033247: 8013-01-080
• 00887868033230: 8013-01-075
• 00887868033223: 8013-01-070
• 00887868033216: 8013-01-060
• 00887868033209: 8013-01-050
• 00887868033193: 8013-00-140
• 00887868033186: 8013-00-130
• 00887868033179: 8013-00-120
• 00887868033162: 8013-00-110
• 00887868033155: 8013-00-105
• 00887868033148: 8013-00-100
• 00887868033131: 8013-00-095
• 00887868033124: 8013-00-090
• 00887868033117: 8013-00-085
• 00887868033100: 8013-00-080
• 00887868033094: 8013-00-075
• 00887868033087: 8013-00-070
• 00887868033070: 8013-00-060
• 00887868033063: 8013-00-050