GUDID 00889024319455

ZIMMER TRABECULAR METAL TECHNOLOGY INC.

Spinal implant trial

• Primary Device ID: 00889024319455
• NIH Device Record Key: 6c2e2ad3-6104-4372-8c07-59dd2697d48c
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 96-161-32131
• 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 Dimensions

• Height: 13 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024319455 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093127

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[00889024319455]

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