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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Cervical
510(k) Number K162682
Device Name MATISSE Anterior Cervical Interbody Fusion Cage System
Applicant
Ctl Medical Corporation
4550 Excel Pkwy.
Suite 300
Addison,  TX  75001
Applicant Contact Tosan Onosode
Correspondent
RQMIS, Inc.
110 Haverhill Rd., Suite 526
Amesbury,  MA  01913
Correspondent Contact Paul Speidel
Regulation Number888.3080
Classification Product Code
ODP  
Date Received09/26/2016
Decision Date 06/01/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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