Carriage 5-6mm CI-CAR-A5-6

GUDID 00810017912452

Carriage 5-6mm

ELEVATION SPINE, INC.

Intervertebral-body internal spinal fixation system

• Primary Device ID: 00810017912452
• NIH Device Record Key: 84f7e1d3-1c31-45ac-9eb9-9877f53e1bf5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Carriage 5-6mm
• Version Model Number: CI-CAR-A5-6
• Catalog Number: CI-CAR-A5-6
• Company DUNS: 085718404
• Company Name: ELEVATION SPINE, 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: true
• Expiration Date: true
• 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: 844-415-0226
• Email: info@elevationspine.com
• Phone: 844-415-0226
• Email: info@elevationspine.com
• Phone: 844-415-0226
• Email: info@elevationspine.com
• Phone: 844-415-0226
• Email: info@elevationspine.com
• Phone: 844-415-0226
• Email: info@elevationspine.com
• Phone: 844-415-0226
• Email: info@elevationspine.com
• Phone: 844-415-0226
• Email: info@elevationspine.com
• Phone: 844-415-0226
• Email: info@elevationspine.com
• Phone: 844-415-0226
• Email: info@elevationspine.com
• Phone: 844-415-0226
• Email: info@elevationspine.com
• Phone: 844-415-0226
• Email: info@elevationspine.com
• Phone: 844-415-0226
• Email: info@elevationspine.com
• Phone: 844-415-0226
• Email: info@elevationspine.com
• Phone: 844-415-0226
• Email: info@elevationspine.com
• Phone: 844-415-0226
• Email: info@elevationspine.com
• Phone: 844-415-0226
• Email: info@elevationspine.com
• Phone: 844-415-0226
• Email: info@elevationspine.com
• Phone: 844-415-0226
• Email: info@elevationspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810017912452 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190885

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-08
• Device Publish Date: 2019-12-31

On-Brand Devices [Carriage 5-6mm]

• 00810017912452: Carriage 5-6mm
• 00810017913435: Carriage 5-6mm