GUDID 00889024319035

ZIMMER TRABECULAR METAL TECHNOLOGY INC.

Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial

• Primary Device ID: 00889024319035
• NIH Device Record Key: e9e8f7c8-23aa-4da6-b82c-381403a026bb
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 96-151-32132
• 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
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0
• Height: 13 Millimeter
• Device Size Text, specify: 0
• Height: 13 Millimeter
• Device Size Text, specify: 0
• Height: 13 Millimeter
• Device Size Text, specify: 0
• Height: 13 Millimeter
• Device Size Text, specify: 0
• Height: 13 Millimeter
• Device Size Text, specify: 0
• Height: 13 Millimeter
• Device Size Text, specify: 0
• Height: 13 Millimeter
• Device Size Text, specify: 0
• Height: 13 Millimeter
• Device Size Text, specify: 0
• Height: 13 Millimeter
• Device Size Text, specify: 0
• Height: 13 Millimeter
• Device Size Text, specify: 0
• Height: 13 Millimeter
• Device Size Text, specify: 0
• Height: 13 Millimeter
• Device Size Text, specify: 0
• Height: 13 Millimeter
• Device Size Text, specify: 0
• Height: 13 Millimeter
• Device Size Text, specify: 0
• Height: 13 Millimeter
• Device Size Text, specify: 0
• Height: 13 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024319035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093127

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00889024319035]

Moist Heat or Steam Sterilization

[00889024319035]

Moist Heat or Steam Sterilization

[00889024319035]

Moist Heat or Steam Sterilization

[00889024319035]

Moist Heat or Steam Sterilization

[00889024319035]

Moist Heat or Steam Sterilization

[00889024319035]

Moist Heat or Steam Sterilization

[00889024319035]

Moist Heat or Steam Sterilization

[00889024319035]

Moist Heat or Steam Sterilization

[00889024319035]

Moist Heat or Steam Sterilization

[00889024319035]

Moist Heat or Steam Sterilization

[00889024319035]

Moist Heat or Steam Sterilization

[00889024319035]

Moist Heat or Steam Sterilization

[00889024319035]

Moist Heat or Steam Sterilization

[00889024319035]

Moist Heat or Steam Sterilization

[00889024319035]

Moist Heat or Steam Sterilization

[00889024319035]

Moist Heat or Steam Sterilization

[00889024319035]

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: 2016-05-25

Devices Manufactured by ZIMMER TRABECULAR METAL TECHNOLOGY INC.

• 00889024223790 - TM Ardis®: 2020-06-23
• 00889024316515 - Mergence™-S: 2020-06-23
• 00889024317239 - Mergence™-S: 2020-06-23
• 00889024317307 - Mergence™-S: 2020-06-23
• 00889024317383 - Mergence™-S: 2020-06-23
• 00889024317970 - Mergence™-S: 2020-06-23
• 00889024318045 - Mergence™-S: 2020-06-23
• 00889024318076 - Mergence™-S: 2020-06-23