TK2 ™STANDARD BARREL 841535005

GUDID 00887868052651

Biomet Orthopedics, LLC

Hip internal fixation system Hip internal fixation system Hip internal fixation system Hip internal fixation system Hip internal fixation system Hip internal fixation system Hip internal fixation system Hip internal fixation system Hip internal fixation system Hip internal fixation system Hip internal fixation system Hip internal fixation system Hip internal fixation system Hip internal fixation system Hip internal fixation system Hip internal fixation system

• Primary Device ID: 00887868052651
• NIH Device Record Key: 5e3ed246-130d-4529-b29a-ea743dbc2033
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TK2 ™STANDARD BARREL
• Version Model Number: 8415-35-005
• Catalog Number: 841535005
• 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	00887868052651 [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

[00887868052651]

Moist Heat or Steam Sterilization

[00887868052651]

Moist Heat or Steam Sterilization

[00887868052651]

Moist Heat or Steam Sterilization

[00887868052651]

Moist Heat or Steam Sterilization

[00887868052651]

Moist Heat or Steam Sterilization

[00887868052651]

Moist Heat or Steam Sterilization

[00887868052651]

Moist Heat or Steam Sterilization

[00887868052651]

Moist Heat or Steam Sterilization

[00887868052651]

Moist Heat or Steam Sterilization

[00887868052651]

Moist Heat or Steam Sterilization

[00887868052651]

Moist Heat or Steam Sterilization

[00887868052651]

Moist Heat or Steam Sterilization

[00887868052651]

Moist Heat or Steam Sterilization

[00887868052651]

Moist Heat or Steam Sterilization

[00887868052651]

Moist Heat or Steam Sterilization

[00887868052651]

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 ™STANDARD BARREL]

• 00887868053108: 8415-50-014
• 00887868053092: 8415-50-012
• 00887868053085: 8415-50-010
• 00887868053078: 8415-50-008
• 00887868053061: 8415-50-006
• 00887868053054: 8415-50-005
• 00887868053047: 8415-50-004
• 00887868053030: 8415-50-003
• 00887868053023: 8415-50-002
• 00887868052989: 8415-45-014
• 00887868052972: 8415-45-012
• 00887868052965: 8415-45-010
• 00887868052958: 8415-45-008
• 00887868052941: 8415-45-006
• 00887868052934: 8415-45-005
• 00887868052927: 8415-45-004
• 00887868052910: 8415-45-003
• 00887868052903: 8415-45-002
• 00887868052842: 8415-40-014
• 00887868052835: 8415-40-012
• 00887868052828: 8415-40-010
• 00887868052811: 8415-40-008
• 00887868052804: 8415-40-006
• 00887868052798: 8415-40-005
• 00887868052781: 8415-40-004
• 00887868052774: 8415-40-003
• 00887868052767: 8415-40-002
• 00887868052705: 8415-35-014
• 00887868052699: 8415-35-012
• 00887868052682: 8415-35-010
• 00887868052675: 8415-35-008
• 00887868052668: 8415-35-006
• 00887868052651: 8415-35-005
• 00887868052644: 8415-35-004
• 00887868052637: 8415-35-003
• 00887868052620: 8415-35-002
• 00887868052569: 8415-30-014
• 00887868052552: 8415-30-012
• 00887868052545: 8415-30-010
• 00887868052538: 8415-30-008
• 00887868052521: 8415-30-006
• 00887868052514: 8415-30-005
• 00887868052507: 8415-30-004
• 00887868052491: 8415-30-003
• 00887868052484: 8415-30-002