EQUATION™ Fixation System

GUDID 00721902602733

SCREW XD60622-5-45 EQU PEDICULAR 5.5X45

MEDTRONIC SOFAMOR DANEK, INC.

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

• Primary Device ID: 00721902602733
• NIH Device Record Key: ebbf79bb-84fa-464d-959e-58f85ff918a2
• Commercial Distribution Discontinuation: 2019-01-11
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: EQUATION™ Fixation System
• Version Model Number: XD60622-5-45
• 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

• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter
• Length: 45 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00721902602733 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013962

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation

Sterilization

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

[00721902602733]

Moist Heat or Steam Sterilization

[00721902602733]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-15
• Device Publish Date: 2015-07-31

On-Brand Devices [EQUATION™ Fixation System]

• 00721902602771: SCREW XD60622-6-45 EQU PEDICULAR 6.5X45
• 00721902602757: SCREW XD60622-6-40 EQU PEDICULAR 6.5X40
• 00721902602733: SCREW XD60622-5-45 EQU PEDICULAR 5.5X45
• 00721902602726: SCREW XD60622-5-40 EQU PEDICULAR 5.5X40
• 00721902581496: SCREW XD606213S EQU SHORT PLUG
• 00721902581458: SCREW XD606213L EQU LONG PLUG