TRAVERSE(TM) OCT Spinal Fixation System

GUDID 00613994212559

SCREW 7755720PT 3.5 X 20MM MA P T SCREW

MEDTRONIC SOFAMOR DANEK, INC.

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

• Primary Device ID: 00613994212559
• NIH Device Record Key: 0bbd44bc-9911-4388-bd9d-8169ffa4ee6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRAVERSE(TM) OCT Spinal Fixation System
• Version Model Number: 7755720PT
• 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: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994212559 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062879

FDA Product Code

• MNI: ORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

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

[00613994212559]

Moist Heat or Steam Sterilization

[00613994212559]

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(TM) OCT Spinal Fixation System]

• 00613994212573: SCREW 7755722PT 3.5 X 22MM MA P T SCREW
• 00613994212559: SCREW 7755720PT 3.5 X 20MM MA P T SCREW
• 00613994212535: SCREW 7755718PT 3.5 X 18MM MA P T SCREW