Cortera Spinal Fixation System

GUDID 00840311247967

ROD INSERTER, MIS, 90DEG, SUB, BODY, MT, SLIM

Xtant Medical Holdings, Inc.

Surgical implant handling forceps Surgical implant handling forceps Surgical implant handling forceps Surgical implant handling forceps Surgical implant handling forceps Surgical implant handling forceps Surgical implant handling forceps Surgical implant handling forceps Surgical implant handling forceps Surgical implant handling forceps Surgical implant handling forceps Surgical implant handling forceps Surgical implant handling forceps Surgical implant handling forceps Surgical implant handling forceps Surgical implant handling forceps Surgical implant handling forceps

• Primary Device ID: 00840311247967
• NIH Device Record Key: 04c6e047-6489-4ae3-acb7-4b6cef5d15c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cortera Spinal Fixation System
• Version Model Number: 1505-001904-S
• Company DUNS: 081224143
• Company Name: Xtant Medical Holdings, 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840311247967 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221403

FDA Product Code

• HTD: Forceps

Sterilization

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

[00840311247967]

Moist Heat or Steam Sterilization

[00840311247967]

Moist Heat or Steam Sterilization

[00840311247967]

Moist Heat or Steam Sterilization

[00840311247967]

Moist Heat or Steam Sterilization

[00840311247967]

Moist Heat or Steam Sterilization

[00840311247967]

Moist Heat or Steam Sterilization

[00840311247967]

Moist Heat or Steam Sterilization

[00840311247967]

Moist Heat or Steam Sterilization

[00840311247967]

Moist Heat or Steam Sterilization

[00840311247967]

Moist Heat or Steam Sterilization

[00840311247967]

Moist Heat or Steam Sterilization

[00840311247967]

Moist Heat or Steam Sterilization

[00840311247967]

Moist Heat or Steam Sterilization

[00840311247967]

Moist Heat or Steam Sterilization

[00840311247967]

Moist Heat or Steam Sterilization

[00840311247967]

Moist Heat or Steam Sterilization

[00840311247967]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-10
• Device Publish Date: 2024-05-31

On-Brand Devices [Cortera Spinal Fixation System]

• 00840311247929: CORTERA, 30° ANGLED DEROTATOR
• 00840311247967: ROD INSERTER, MIS, 90DEG, SUB, BODY, MT, SLIM