CD Horizon® Ballast™ Spinal System

GUDID 00643169523852

TRAY 2950006 NAVIGATION INSTRUMENTS

MEDTRONIC SOFAMOR DANEK, INC.

Instrument tray

• Primary Device ID: 00643169523852
• NIH Device Record Key: ceb597e9-91ad-4beb-a7f3-76411bf2e38d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CD Horizon® Ballast™ Spinal System
• Version Model Number: 2950006
• 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: true
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169523852 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153442

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[00643169523852]

Moist Heat or Steam Sterilization

[00643169523852]

Moist Heat or Steam Sterilization

[00643169523852]

Moist Heat or Steam Sterilization

[00643169523852]

Moist Heat or Steam Sterilization

[00643169523852]

Moist Heat or Steam Sterilization

[00643169523852]

Moist Heat or Steam Sterilization

[00643169523852]

Moist Heat or Steam Sterilization

[00643169523852]

Moist Heat or Steam Sterilization

[00643169523852]

Moist Heat or Steam Sterilization

[00643169523852]

Moist Heat or Steam Sterilization

[00643169523852]

Moist Heat or Steam Sterilization

[00643169523852]

Moist Heat or Steam Sterilization

[00643169523852]

Moist Heat or Steam Sterilization

[00643169523852]

Moist Heat or Steam Sterilization

[00643169523852]

Moist Heat or Steam Sterilization

[00643169523852]

Moist Heat or Steam Sterilization

[00643169523852]

Moist Heat or Steam Sterilization

[00643169523852]

Moist Heat or Steam Sterilization

[00643169523852]

Moist Heat or Steam Sterilization

[00643169523852]

Moist Heat or Steam Sterilization

[00643169523852]

Moist Heat or Steam Sterilization

[00643169523852]

Moist Heat or Steam Sterilization

[00643169523852]

Moist Heat or Steam Sterilization

[00643169523852]

Moist Heat or Steam Sterilization

[00643169523852]

Moist Heat or Steam Sterilization

[00643169523852]

Moist Heat or Steam Sterilization

[00643169523852]

Moist Heat or Steam Sterilization

[00643169523852]

Moist Heat or Steam Sterilization

[00643169523852]

Moist Heat or Steam Sterilization

[00643169523852]

Moist Heat or Steam Sterilization

[00643169523852]

Moist Heat or Steam Sterilization

[00643169523852]

Moist Heat or Steam Sterilization

[00643169523852]

Moist Heat or Steam Sterilization

[00643169523852]

Moist Heat or Steam Sterilization

[00643169523852]

Moist Heat or Steam Sterilization

[00643169523852]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-08-09
• Device Publish Date: 2017-12-15

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

• 00885074240695 - n/a: 2025-09-30 ACCESSORIES 3299003 GRAFT TAMP
• 00199150026029 - Medtronic Reusable Instruments: 2025-09-29 COMPRESSOR X0525001 RACK AND PINION
• 00763000684044 - Medtronic Reusable Instruments: 2025-09-29 INSTRUMENT 950-146 RULER
• 00763000856700 - VERTE-STACK® Spinal System: 2025-09-29 STRUT 6242064 ANATOMIC 16X14X24MM
• 00763000879563 - ENDOSKELETON® TCS: 2025-09-29 HANDLE 5210-1016 TCS RATCHETING HANDLE
• 00763000879587 - ENDOSKELETON® TCS: 2025-09-29 DRIVER 5210-1004 TCS NO 8 HEX STRAIGHT
• 00763000879600 - ENDOSKELETON® TCS: 2025-09-29 DRIVER 5210-1024 TCS NO 8 HEX U-JOINT
• 00763000879648 - Endoskeleton™ TCS Interbody System: 2025-09-29 AWL 5210-1062 TCS STRAIGHT FIXED 2MM