DYNA-LOK® Spinal System

GUDID 00673978150857

DYN 10MM 10-32 STUD TI

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00673978150857
• NIH Device Record Key: b83d5d4c-f91b-4fb9-8438-944f4b4ecd04
• Commercial Distribution Discontinuation: 2018-10-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: DYNA-LOK® Spinal System
• Version Model Number: X1096-034
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Width: 10 Millimeter
• Width: 10 Millimeter
• Width: 10 Millimeter
• Width: 10 Millimeter
• Width: 10 Millimeter
• Width: 10 Millimeter
• Width: 10 Millimeter
• Width: 10 Millimeter
• Width: 10 Millimeter
• Width: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00673978150857 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K936307

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation

Sterilization

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

[00673978150857]

Moist Heat or Steam Sterilization

[00673978150857]

Moist Heat or Steam Sterilization

[00673978150857]

Moist Heat or Steam Sterilization

[00673978150857]

Moist Heat or Steam Sterilization

[00673978150857]

Moist Heat or Steam Sterilization

[00673978150857]

Moist Heat or Steam Sterilization

[00673978150857]

Moist Heat or Steam Sterilization

[00673978150857]

Moist Heat or Steam Sterilization

[00673978150857]

Moist Heat or Steam Sterilization

[00673978150857]

Moist Heat or Steam Sterilization

[00673978150857]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-29
• Device Publish Date: 2015-08-18

On-Brand Devices [DYNA-LOK® Spinal System]

• 00673978150864: DYN 10-32 NUT TI
• 00673978150857: DYN 10MM 10-32 STUD TI
• 00673978130972: DYN 16MM 10-32 STUD TI
• 00673978130965: DYN 14MM 10-32 STUD TI
• 00673978130958: DYN 12MM 10-32 STUD TI