MATISSE Anterior Cervical Interbidy Fusion System

GUDID 00841732116979

CTL MEDICAL CORPORATION

Polymeric spinal interbody fusion cage

• Primary Device ID: 00841732116979
• NIH Device Record Key: be0d8052-0839-42a8-9ad1-8983849d92e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MATISSE Anterior Cervical Interbidy Fusion System
• Version Model Number: 013.4160B
• Company DUNS: 080138504
• Company Name: CTL MEDICAL CORPORATION
• 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: 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(214)545-5820
• Email: complaints@ctlmed.com

Device Dimensions

• Width: 17 Millimeter
• Width: 17 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841732116979 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121569

FDA Product Code

• ODP: Intervertebral fusion device with bone graft, cervical

Sterilization

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

[00841732116979]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-09-19

On-Brand Devices [MATISSE Anterior Cervical Interbidy Fusion System]

• 00841732116979: 013.4160B
• 00841732116962: 013.4159B
• 00841732116955: 013.4158B
• 00841732116948: 013.4157B
• 00841732116931: 013.4156B
• 00841732116924: 013.4155B