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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 K121569
Device Name MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM
Applicant
ACCEL SPINE
14850 Quorum Dr Ste 220
Dallas,  TX  75254
Applicant Contact DANIEL CHON
Correspondent
ACCEL SPINE
14850 Quorum Dr Ste 220
Dallas,  TX  75254
Correspondent Contact DANIEL CHON
Regulation Number888.3080
Classification Product Code
ODP  
Date Received05/29/2012
Decision Date 07/27/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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