TM Total Ankle 82-0175-162-00

GUDID 00889024471375

Zimmer, Inc.

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 00889024471375
• NIH Device Record Key: 87bbb7af-5448-4962-8f3d-e93c32f7728c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TM Total Ankle
• Version Model Number: 82-0175-162-00
• Catalog Number: 82-0175-162-00
• Company DUNS: 056038268
• Company Name: Zimmer, Inc.
• 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: false
• Lot Batch: false
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024471375 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120906

FDA Product Code

• HSN: Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

Sterilization

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

[00889024471375]

Moist Heat or Steam Sterilization

[00889024471375]

Moist Heat or Steam Sterilization

[00889024471375]

Moist Heat or Steam Sterilization

[00889024471375]

Moist Heat or Steam Sterilization

[00889024471375]

Moist Heat or Steam Sterilization

[00889024471375]

Moist Heat or Steam Sterilization

[00889024471375]

Moist Heat or Steam Sterilization

[00889024471375]

Moist Heat or Steam Sterilization

[00889024471375]

Moist Heat or Steam Sterilization

[00889024471375]

Moist Heat or Steam Sterilization

[00889024471375]

Moist Heat or Steam Sterilization

[00889024471375]

Moist Heat or Steam Sterilization

[00889024471375]

Moist Heat or Steam Sterilization

[00889024471375]

Moist Heat or Steam Sterilization

[00889024471375]

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: 2016-11-30

Devices Manufactured by Zimmer, Inc.

• 00887868585661 - Zimmer Biomet® 12/14 Spherical Head Trials: 2024-11-19
• 00887868139628 - Affixus®: 2024-11-18
• 00887868139635 - Affixus®: 2024-11-18
• 00887868139642 - Affixus®: 2024-11-18
• 00887868139659 - Affixus®: 2024-11-18
• 00887868139666 - Affixus®: 2024-11-18
• 00887868139673 - Affixus®: 2024-11-18
• 00887868139680 - Affixus®: 2024-11-18