Vertex(TM) Reconstruction System

GUDID 00721902545696

VER HK-TI-CL-O/S-SIDELOAD-XL

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00721902545696
• NIH Device Record Key: e88c65e4-6608-472a-b5e0-7b571deef0e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vertex(TM) Reconstruction System
• Version Model Number: X6904090
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, 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: 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)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00721902545696 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003780

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[00721902545696]

Moist Heat or Steam Sterilization

[00721902545696]

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: 2015-08-18

On-Brand Devices [Vertex(TM) Reconstruction System]

• 00721902545696: VER HK-TI-CL-O/S-SIDELOAD-XL
• 00721902545689: VER HK-TI-CL-O/S-SIDELOAD-LG
• 00721902545672: VER HK-TI-CL-O/S-SIDELOAD-MD
• 00721902545665: VER HK-TI-CL-O/S-SIDELOAD-SM