TM Ardis®

GUDID 00889024223783

ZIMMER TRABECULAR METAL TECHNOLOGY INC.

Spinal implant trial

• Primary Device ID: 00889024223783
• NIH Device Record Key: 091250e1-253d-4d3b-bbdc-5029fa69e053
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TM Ardis®
• Version Model Number: 96-701-04071
• Company DUNS: 793120965
• Company Name: ZIMMER TRABECULAR METAL TECHNOLOGY 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: 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)348-2759
• Email: zimmer.consumerrelations@zimmer.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024223783 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113561

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00889024223783]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-05-26

On-Brand Devices [TM Ardis®]

• 00889024320635: 96-701-30001
• 00889024320628: 96-701-21161
• 00889024320611: 96-701-21121
• 00889024320604: 96-701-21101
• 00889024320598: 96-701-21081
• 00889024320581: 96-701-20161
• 00889024320574: 96-701-20121
• 00889024320567: 96-701-20101
• 00889024320550: 96-701-20081
• 00889024320543: 96-701-10001
• 00889024223813: 96-701-31001
• 00889024223806: 96-701-06071
• 00889024223790: 96-701-05071
• 00889024223783: 96-701-04071
• 00889024223776: 96-701-03071
• 00889024223769: 96-701-02071
• 00889024223752: 96-701-01071