DYNALOK PLUS™ Spinal System

GUDID 00673978950037

SCREW 8430006 DY AUTO BREAK OFF NUT TI

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding)

• Primary Device ID: 00673978950037
• NIH Device Record Key: 95cd8eda-7e10-42f4-8884-0942627f726f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DYNALOK PLUS™ Spinal System
• Version Model Number: 8430006
• 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
• 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	00673978950037 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991364

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[00673978950037]

Moist Heat or Steam Sterilization

[00673978950037]

Moist Heat or Steam Sterilization

[00673978950037]

Moist Heat or Steam Sterilization

[00673978950037]

Moist Heat or Steam Sterilization

[00673978950037]

Moist Heat or Steam Sterilization

[00673978950037]

Moist Heat or Steam Sterilization

[00673978950037]

Moist Heat or Steam Sterilization

[00673978950037]

Moist Heat or Steam Sterilization

[00673978950037]

Moist Heat or Steam Sterilization

[00673978950037]

Moist Heat or Steam Sterilization

[00673978950037]

Moist Heat or Steam Sterilization

[00673978950037]

Moist Heat or Steam Sterilization

[00673978950037]

Moist Heat or Steam Sterilization

[00673978950037]

Moist Heat or Steam Sterilization

[00673978950037]

Moist Heat or Steam Sterilization

[00673978950037]

Moist Heat or Steam Sterilization

[00673978950037]

Moist Heat or Steam Sterilization

[00673978950037]

Moist Heat or Steam Sterilization

[00673978950037]

Moist Heat or Steam Sterilization

[00673978950037]

Moist Heat or Steam Sterilization

[00673978950037]

Moist Heat or Steam Sterilization

[00673978950037]

Moist Heat or Steam Sterilization

[00673978950037]

Moist Heat or Steam Sterilization

[00673978950037]

Moist Heat or Steam Sterilization

[00673978950037]

Moist Heat or Steam Sterilization

[00673978950037]

Moist Heat or Steam Sterilization

[00673978950037]

Moist Heat or Steam Sterilization

[00673978950037]

Moist Heat or Steam Sterilization

[00673978950037]

Moist Heat or Steam Sterilization

[00673978950037]

Moist Heat or Steam Sterilization

[00673978950037]

Moist Heat or Steam Sterilization

[00673978950037]

Moist Heat or Steam Sterilization

[00673978950037]

Moist Heat or Steam Sterilization

[00673978950037]

Moist Heat or Steam Sterilization

[00673978950037]

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: 2015-08-19

On-Brand Devices [DYNALOK PLUS™ Spinal System]

• 00673978973036: CONNECTOR 8436072C 6.35MM EXTENDED
• 00673978972978: CONNECTOR 8436056C 6.35MM STRAIGHT
• 00673978950037: SCREW 8430006 DY AUTO BREAK OFF NUT TI
• 00673978928807: SCREW 8430005 DY NON BREAK OFF NUT TI
• 00721902973666: CONNECTOR X0880455R 5.5 CLOSE RT OFFSET
• 00721902973659: CONNECTOR X0880455L 5.5 CLOSE LT OFFSET