TM Ardis® Trabecular Metal™

GUDID 00889024315747

ZIMMER TRABECULAR METAL TECHNOLOGY INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00889024315747
• NIH Device Record Key: cdf6c041-e9cd-4dc1-8582-cef0d604e8e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TM Ardis® Trabecular Metal™
• Version Model Number: 06-701-02081
• 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: 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)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com

Device Dimensions

• Height: 8 Millimeter
• Height: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024315747 [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: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-09-17

On-Brand Devices [TM Ardis® Trabecular Metal™]

• 00889024316133: 06-701-06161
• 00889024316126: 06-701-06141
• 00889024316119: 06-701-06131
• 00889024316102: 06-701-06121
• 00889024316096: 06-701-06111
• 00889024316089: 06-701-06101
• 00889024316072: 06-701-06091
• 00889024316065: 06-701-06081
• 00889024316058: 06-701-05161
• 00889024316041: 06-701-05141
• 00889024316034: 06-701-05131
• 00889024316027: 06-701-05121
• 00889024316010: 06-701-05111
• 00889024316003: 06-701-05101
• 00889024315990: 06-701-05091
• 00889024315983: 06-701-05081
• 00889024315976: 06-701-04161
• 00889024315969: 06-701-04141
• 00889024315952: 06-701-04131
• 00889024315945: 06-701-04121
• 00889024315938: 06-701-04111
• 00889024315921: 06-701-04101
• 00889024315914: 06-701-04091
• 00889024315907: 06-701-04081
• 00889024315891: 06-701-03161
• 00889024315884: 06-701-03141
• 00889024315877: 06-701-03131
• 00889024315860: 06-701-03121
• 00889024315853: 06-701-03111
• 00889024315846: 06-701-03101
• 00889024315839: 06-701-03091
• 00889024315822: 06-701-03081
• 00889024315815: 06-701-02161
• 00889024315808: 06-701-02141
• 00889024315792: 06-701-02131
• 00889024315785: 06-701-02121
• 00889024315778: 06-701-02111
• 00889024315761: 06-701-02101
• 00889024315754: 06-701-02091
• 00889024315747: 06-701-02081