Trial Head 14x15x6 9 deg. CI-TH4596

GUDID 00810017912995

Trial Head 14x15x6 9 deg.

ELEVATION SPINE, INC.

Intervertebral-body internal spinal fixation system

• Primary Device ID: 00810017912995
• NIH Device Record Key: eeceaa77-2515-4c74-a4a4-d3ad471dd665
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trial Head 14x15x6 9 deg.
• Version Model Number: CI-TH4596
• Catalog Number: CI-TH4596
• 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	00810017912995 [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: 2020-01-14
• Device Publish Date: 2020-01-06

Devices Manufactured by ELEVATION SPINE, INC.

• 00810017914777 - Double Ended Rasp/Trial 12x15x5, 6°: 2025-04-07 Double Ended Rasp/Trial 12x15x5, 6°
• 00810017914784 - Double Ended Rasp/Trial 12x15x6, 6°: 2025-04-07 Double Ended Rasp/Trial 12x15x6, 6°
• 00810017914791 - Double Ended Rasp/Trial 12x15x7, 6°: 2025-04-07 Double Ended Rasp/Trial 12x15x7, 6°
• 00810017914807 - Double Ended Rasp/Trial 12x15x8, 6°: 2025-04-07 Double Ended Rasp/Trial 12x15x8, 6°
• 00810017914814 - Double Ended Rasp/Trial 12x15x9, 6°: 2025-04-07 Double Ended Rasp/Trial 12x15x9, 6°
• 00810017914821 - Double Ended Rasp/Trial 14x17x5, 6°: 2025-04-07 Double Ended Rasp/Trial 14x17x5, 6°
• 00810017914838 - Double Ended Rasp/Trial 14x17x6, 6°: 2025-04-07 Double Ended Rasp/Trial 14x17x6, 6°
• 00810017914845 - Double Ended Rasp/Trial 14x17x7, 6°: 2025-04-07 Double Ended Rasp/Trial 14x17x7, 6°