BASIS™ Spinal System

GUDID 00885074104836

SPACER 8652263 12 26MM X 3 VBS TI

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00885074104836
• NIH Device Record Key: 69c1ab2a-1d40-4f71-9c28-7c951042b4a7
• Commercial Distribution Discontinuation: 2018-10-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: BASIS™ Spinal System
• Version Model Number: 8652263
• 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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885074104836 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051105

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[00885074104836]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-01-31
• Device Publish Date: 2015-08-07

On-Brand Devices [BASIS™ Spinal System]

• 00885074104843: SPACER 8658223 8 22MM X 3 VBS TI
• 00885074104836: SPACER 8652263 12 26MM X 3 VBS TI
• 00885074104829: SPACER 8652223 12 22MM X 3 VBS TI
• 00885074104805: SPACER 8650263 10 26MM X 3 VBS TI
• 00885074104782: SPACER 8650223 10 22MM X 3 VBS TI