CD HORIZON SPIRE™Z Spinal System

GUDID 00643169167445

INSERTER/COMPRESSOR 9240600 SPIRE Z

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic fixation implant alignment tool Orthopaedic fixation implant alignment tool

• Primary Device ID: 00643169167445
• NIH Device Record Key: 314c1f20-daad-44f7-9c4e-0ff453fe0047
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CD HORIZON SPIRE™Z Spinal System
• Version Model Number: 9240600
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169167445 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123246

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[00643169167445]

Moist Heat or Steam Sterilization

[00643169167445]

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: 2016-04-18

On-Brand Devices [CD HORIZON SPIRE™Z Spinal System]

• 00643169177536: CADDY 9240650 BOTTOM LID
• 00643169177529: CADDY 9240640 TOP LID
• 00643169177512: CADDY 9240630 BODY
• 00643169177505: TRAY 9240620 INSTRUMENT INNER
• 00643169167445: INSERTER/COMPRESSOR 9240600 SPIRE Z