MSB TELAMON Spinal System

GUDID 00673978958408

INSTRUMENT 907-544 TAN DISTRCTR 14

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic surgical distractor, internal

• Primary Device ID: 00673978958408
• NIH Device Record Key: b6ecbdc3-70e6-4248-b3c8-89b61f9c3c6c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MSB TELAMON Spinal System
• Version Model Number: 907-544
• 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: false
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00673978958408 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110562

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00673978958408]

Moist Heat or Steam Sterilization

[00673978958408]

Moist Heat or Steam Sterilization

[00673978958408]

Moist Heat or Steam Sterilization

[00673978958408]

Moist Heat or Steam Sterilization

[00673978958408]

Moist Heat or Steam Sterilization

[00673978958408]

Moist Heat or Steam Sterilization

[00673978958408]

Moist Heat or Steam Sterilization

[00673978958408]

Moist Heat or Steam Sterilization

[00673978958408]

Moist Heat or Steam Sterilization

[00673978958408]

Moist Heat or Steam Sterilization

[00673978958408]

Moist Heat or Steam Sterilization

[00673978958408]

Moist Heat or Steam Sterilization

[00673978958408]

Moist Heat or Steam Sterilization

[00673978958408]

Moist Heat or Steam Sterilization

[00673978958408]

Moist Heat or Steam Sterilization

[00673978958408]

Moist Heat or Steam Sterilization

[00673978958408]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-30
• Device Publish Date: 2024-07-22

On-Brand Devices [MSB TELAMON Spinal System]

• 00673978958408: INSTRUMENT 907-544 TAN DISTRCTR 14
• 00673978929330: INSTRUMENT 907-548 TAN DISCDISTRACTOR 8
• 00673978929323: INSTRUMENT 907-547 TAN DISCDISTRACTOR 7
• 00673978929293: INSTRUMENT 907-542 TAN DISTRCTR 12
• 00673978929279: INSTRUMENT 907-540 TAN DISTRCTR 10