MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™

Intervertebral Fusion Device With Bone Graft, Cervical

CTL Medical Corporation

The following data is part of a premarket notification filed by Ctl Medical Corporation with the FDA for Matisse Anterior Cervical Interbody Fusion Cage System, Ti-peek™.

Pre-market Notification Details

Device IDK172212
510k NumberK172212
Device Name:MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant CTL Medical Corporation 4550 Excel Parkway, Suite 300 Addison,  TX  75001
ContactTosan Onosode
CorrespondentPaul Speidel
Rqmis, Inc. 110 Haverhill Road, Suite 526 Amesbury,  MA  01913
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-24
Decision Date2018-01-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00841732125100 K172212 000
00841732125025 K172212 000
00841732125032 K172212 000
00841732125049 K172212 000
00841732125056 K172212 000
00841732125063 K172212 000
00841732125070 K172212 000
00841732125087 K172212 000
00841732125094 K172212 000
00841732125018 K172212 000

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