Spike Driver, 10mm CI-DRIVER-SP-10

GUDID 00810017913244

Spike Driver, 10mm

ELEVATION SPINE, INC.

Intervertebral-body internal spinal fixation system

• Primary Device ID: 00810017913244
• NIH Device Record Key: e58f49d2-84de-4a6b-8b9b-6344d80b389f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spike Driver, 10mm
• Version Model Number: CI-DRIVER-SP-10
• Catalog Number: CI-DRIVER-SP-10
• 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	00810017913244 [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: 2020-01-16
• Device Publish Date: 2020-01-08

On-Brand Devices [Spike Driver, 10mm]

• 00810017913244: Spike Driver, 10mm
• 00810017913565: Spike Driver, 10mm