MATISSE Anterior Cervical Interbody Fusion Cage System

GUDID 00841732105379

MATISSE ACIF Cage, PEEK, W20 x L16, 6Deg., H6mm

CTL MEDICAL CORPORATION

Polymeric spinal interbody fusion cage

• Primary Device ID: 00841732105379
• NIH Device Record Key: ca862099-b820-4ce6-9f0c-127147254201
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MATISSE Anterior Cervical Interbody Fusion Cage System
• Version Model Number: 013.4196
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Height: 6 Millimeter
• Width: 20 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Height: 6 Millimeter
• Width: 20 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Height: 6 Millimeter
• Width: 20 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Height: 6 Millimeter
• Width: 20 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Height: 6 Millimeter
• Width: 20 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Height: 6 Millimeter
• Width: 20 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Height: 6 Millimeter
• Width: 20 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Height: 6 Millimeter
• Width: 20 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Height: 6 Millimeter
• Width: 20 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Height: 6 Millimeter
• Width: 20 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Height: 6 Millimeter
• Width: 20 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Height: 6 Millimeter
• Width: 20 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Height: 6 Millimeter
• Width: 20 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Height: 6 Millimeter
• Width: 20 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Height: 6 Millimeter
• Width: 20 Millimeter
• Device Size Text, specify: 0
• Length: 16 Millimeter
• Height: 6 Millimeter
• Width: 20 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841732105379 [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: false

[00841732105379]

Moist Heat or Steam Sterilization

[00841732105379]

Moist Heat or Steam Sterilization

[00841732105379]

Moist Heat or Steam Sterilization

[00841732105379]

Moist Heat or Steam Sterilization

[00841732105379]

Moist Heat or Steam Sterilization

[00841732105379]

Moist Heat or Steam Sterilization

[00841732105379]

Moist Heat or Steam Sterilization

[00841732105379]

Moist Heat or Steam Sterilization

[00841732105379]

Moist Heat or Steam Sterilization

[00841732105379]

Moist Heat or Steam Sterilization

[00841732105379]

Moist Heat or Steam Sterilization

[00841732105379]

Moist Heat or Steam Sterilization

[00841732105379]

Moist Heat or Steam Sterilization

[00841732105379]

Moist Heat or Steam Sterilization

[00841732105379]

Moist Heat or Steam Sterilization

[00841732105379]

Moist Heat or Steam Sterilization

[00841732105379]

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: 2016-03-05

On-Brand Devices [MATISSE Anterior Cervical Interbody Fusion Cage System]

• 00841732106208: ACIF Trial - W20 x L16, 6Deg., H10mm
• 00841732106192: ACIF Trial - W20 x L16, 6Deg., H9mm
• 00841732106185: ACIF Trial - W20 x L16, 6Deg., H8mm
• 00841732106178: ACIF Trial - W20 x L16, 6Deg., H7mm
• 00841732106161: ACIF Trial - W20 x L16, 6Deg., H6mm
• 00841732106154: ACIF Trial - W20 x L16, 6Deg., H5mm
• 00841732106147: ACIF Trial - W20 x L16, 0Deg., H10mm
• 00841732106130: ACIF Trial - W20 x L16, 0Deg., H9mm
• 00841732106123: ACIF Trial - W20 x L16, 0Deg., H8mm
• 00841732106116: ACIF Trial - W20 x L16, 0Deg., H7mm
• 00841732106109: ACIF Trial - W20 x L16, 0Deg., H6mm
• 00841732106093: ACIF Trial - W20 x L16, 0Deg., H5mm
• 00841732106086: ACIF Trial - W17 x L14, 6Deg., H10mm
• 00841732106079: ACIF Trial - W17 x L14, 6Deg., H9mm
• 00841732106062: ACIF Trial - W17 x L14, 6Deg., H8mm
• 00841732106055: ACIF Trial - W17 x L14, 6Deg., H7mm
• 00841732106048: ACIF Trial - W17 x L14, 6Deg., H6mm
• 00841732106031: ACIF Trial - W17 x L14, 6Deg., H5mm
• 00841732106024: ACIF Trial - W17 x L14, 0Deg., H10mm
• 00841732106017: ACIF Trial - W17 x L14, 0Deg., H9mm
• 00841732106000: ACIF Trial - W17 x L14, 0Deg., H8mm
• 00841732105997: ACIF Trial - W17 x L14, 0Deg., H7mm
• 00841732105980: ACIF Trial - W17 x L14, 0Deg., H6mm
• 00841732105973: ACIF Trial - W17 x L14, 0Deg., H5mm
• 00841732105966: ACIF Trial - W14 x L12, 6Deg., H10mm
• 00841732105959: ACIF Trial - W14 x L12, 6Deg., H9mm
• 00841732105942: ACIF Trial - W14 x L12, 6Deg., H8mm
• 00841732105935: ACIF Trial - W14 x L12, 6Deg., H7mm
• 00841732105928: ACIF Trial - W14 x L12, 6Deg., H6mm
• 00841732105911: ACIF Trial - W14 x L12, 6Deg., H5mm
• 00841732105904: ACIF Trial - W14 x L12, 0Deg., H10mm
• 00841732105898: ACIF Trial - W14 x L12, 0Deg., H9mm
• 00841732105881: ACIF Trial - W14 x L12, 0Deg., H8mm
• 00841732105874: ACIF Trial - W14 x L12, 0Deg., H7mm
• 00841732105867: ACIF Trial - W14 x L12, 0Deg., H6mm
• 00841732105850: ACIF Trial - W14 x L12, 0Deg., H5mm
• 00841732105843: ACIF Cage Impactor
• 00841732105812: ACIF Modular Trial Inserter
• 00841732105799: ACIF Trial - W14xL12 / W17xL14, H10mm
• 00841732105782: ACIF Trial - W14xL12 / W17xL14, H9mm
• 00841732105775: ACIF Trial - W14xL12 / W17xL14, H8mm
• 00841732105768: ACIF Trial - W14xL12 / W17xL14, H7mm
• 00841732105751: ACIF Trial - W14xL12 / W17xL14, H6mm
• 00841732105744: ACIF Trial - W14xL12 / W17xL14, H5mm
• 00841732105737: ACIF Rasp - W14 x L12, H10mm
• 00841732105720: ACIF Rasp - W14 x L12, H9mm
• 00841732105713: ACIF Rasp - W14 x L12, H8mm
• 00841732105706: ACIF Rasp - W14 x L12, H7mm
• 00841732105690: ACIF Rasp - W14 x L12, H6mm
• 00841732105683: ACIF Rasp - W14 x L12, H5mm