TRAVERSE™ OCT Spinal Fixation System

GUDID 00613994205643

ROD 7750710EP 3.5X10MM EXT PST BONE SCRW

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00613994205643
• NIH Device Record Key: 50a470ea-a9f6-4f61-bf3e-aeb59fe7a71f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRAVERSE™ OCT Spinal Fixation System
• Version Model Number: 7750710EP
• 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
• 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

• Length: 10 Millimeter
• Length: 10 Millimeter
• Length: 10 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994205643 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062447

FDA Product Code

• MNI: ORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

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

[00613994205643]

Moist Heat or Steam Sterilization

[00613994205643]

Moist Heat or Steam Sterilization

[00613994205643]

Moist Heat or Steam Sterilization

[00613994205643]

Moist Heat or Steam Sterilization

[00613994205643]

Moist Heat or Steam Sterilization

[00613994205643]

Moist Heat or Steam Sterilization

[00613994205643]

Moist Heat or Steam Sterilization

[00613994205643]

Moist Heat or Steam Sterilization

[00613994205643]

Moist Heat or Steam Sterilization

[00613994205643]

Moist Heat or Steam Sterilization

[00613994205643]

Moist Heat or Steam Sterilization

[00613994205643]

Moist Heat or Steam Sterilization

[00613994205643]

Moist Heat or Steam Sterilization

[00613994205643]

Moist Heat or Steam Sterilization

[00613994205643]

Moist Heat or Steam Sterilization

[00613994205643]

Moist Heat or Steam Sterilization

[00613994205643]

Moist Heat or Steam Sterilization

[00613994205643]

Moist Heat or Steam Sterilization

[00613994205643]

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: 2015-07-08

On-Brand Devices [TRAVERSE™ OCT Spinal Fixation System]

• 00613994207661: ROD 7751012 5.0X 12MM POSTED BONE SCREW
• 00613994207654: ROD 7751010EP 5.0X10MM EXT PST BONE SCRW
• 00613994207647: ROD 7751010 5.0X 10MM POSTED BONE SCREW
• 00613994206374: ROD 7751008EP 5.0X8MM EXT PST BONE SCRW
• 00613994205643: ROD 7750710EP 3.5X10MM EXT PST BONE SCRW
• 00613994205612: ROD 7751008 5.0X 8MM POSTED BONE SCREW