MATISSE Anterior Cervical Interbody Fusion Cage System

GUDID 00841732105560

MATISSE ACIF Cage, PEEK - W17 x L14, H7mm (Convex)

CTL MEDICAL CORPORATION

Polymeric spinal interbody fusion cage
Primary Device ID00841732105560
NIH Device Record Key16ea8fcd-8bd3-4c63-9f36-077ed67f4036
Commercial Distribution StatusIn Commercial Distribution
Brand NameMATISSE Anterior Cervical Interbody Fusion Cage System
Version Model Number013.4737
Company DUNS080138504
Company NameCTL MEDICAL CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(214)545-5820
Emailcomplaints@ctlmed.com
Phone+1(214)545-5820
Emailcomplaints@ctlmed.com
Phone+1(214)545-5820
Emailcomplaints@ctlmed.com
Phone+1(214)545-5820
Emailcomplaints@ctlmed.com
Phone+1(214)545-5820
Emailcomplaints@ctlmed.com
Phone+1(214)545-5820
Emailcomplaints@ctlmed.com
Phone+1(214)545-5820
Emailcomplaints@ctlmed.com
Phone+1(214)545-5820
Emailcomplaints@ctlmed.com
Phone+1(214)545-5820
Emailcomplaints@ctlmed.com
Phone+1(214)545-5820
Emailcomplaints@ctlmed.com
Phone+1(214)545-5820
Emailcomplaints@ctlmed.com
Phone+1(214)545-5820
Emailcomplaints@ctlmed.com
Phone+1(214)545-5820
Emailcomplaints@ctlmed.com
Phone+1(214)545-5820
Emailcomplaints@ctlmed.com
Phone+1(214)545-5820
Emailcomplaints@ctlmed.com
Phone+1(214)545-5820
Emailcomplaints@ctlmed.com
Phone+1(214)545-5820
Emailcomplaints@ctlmed.com

Device Dimensions

Height7 Millimeter
Height7 Millimeter
Height7 Millimeter
Width17 Millimeter
Length14 Millimeter
Height7 Millimeter
Width17 Millimeter
Length14 Millimeter
Height7 Millimeter
Width17 Millimeter
Length14 Millimeter
Height7 Millimeter
Width17 Millimeter
Length14 Millimeter
Height7 Millimeter
Width17 Millimeter
Length14 Millimeter
Height7 Millimeter
Width17 Millimeter
Length14 Millimeter
Height7 Millimeter
Width17 Millimeter
Length14 Millimeter
Height7 Millimeter
Width17 Millimeter
Length14 Millimeter
Height7 Millimeter
Width17 Millimeter
Length14 Millimeter
Height7 Millimeter
Width17 Millimeter
Length14 Millimeter
Height7 Millimeter
Width17 Millimeter
Length14 Millimeter
Height7 Millimeter
Width17 Millimeter
Length14 Millimeter
Height7 Millimeter
Width17 Millimeter
Length14 Millimeter
Height7 Millimeter
Width17 Millimeter
Length14 Millimeter
Height7 Millimeter
Width17 Millimeter
Length14 Millimeter
Height7 Millimeter
Width17 Millimeter
Length14 Millimeter
Height7 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100841732105560 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODPIntervertebral fusion device with bone graft, cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841732105560]

Moist Heat or Steam Sterilization

[00841732105560]

Moist Heat or Steam Sterilization

[00841732105560]

Moist Heat or Steam Sterilization

[00841732105560]

Moist Heat or Steam Sterilization

[00841732105560]

Moist Heat or Steam Sterilization

[00841732105560]

Moist Heat or Steam Sterilization

[00841732105560]

Moist Heat or Steam Sterilization

[00841732105560]

Moist Heat or Steam Sterilization

[00841732105560]

Moist Heat or Steam Sterilization

[00841732105560]

Moist Heat or Steam Sterilization

[00841732105560]

Moist Heat or Steam Sterilization

[00841732105560]

Moist Heat or Steam Sterilization

[00841732105560]

Moist Heat or Steam Sterilization

[00841732105560]

Moist Heat or Steam Sterilization

[00841732105560]

Moist Heat or Steam Sterilization

[00841732105560]

Moist Heat or Steam Sterilization

[00841732105560]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2016-03-05

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

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