MATISSE Ti-Peek

GUDID 00841732125094

CTL MEDICAL CORPORATION

Polymeric spinal interbody fusion cage

• Primary Device ID: 00841732125094
• NIH Device Record Key: 385f0408-0b68-4055-ab95-2ef351206a39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MATISSE Ti-Peek
• Version Model Number: 013.1409
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00841732125094 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172212

FDA Product Code

• ODP: Intervertebral fusion device with bone graft, cervical

Sterilization

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

[00841732125094]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-10-29

On-Brand Devices [MATISSE Ti-Peek]

• 00841732125100: 013.1410
• 00841732125094: 013.1409
• 00841732125087: 013.1408
• 00841732125070: 013.1407
• 00841732125063: 013.1406
• 00841732125056: 013.1810
• 00841732125049: 013.1809
• 00841732125032: 013.1808
• 00841732125025: 013.1807
• 00841732125018: 013.1806