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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K121060
Device Name SPINE FRONTIER INDUS ACP SYSTEM
Applicant
SPINEFRONTIER, INC.
500 CUMMINGS CENTER
SUITE 3500
BEVERLY,  MA  01915
Applicant Contact FREDY H VARELA
Correspondent
SPINEFRONTIER, INC.
500 CUMMINGS CENTER
SUITE 3500
BEVERLY,  MA  01915
Correspondent Contact FREDY H VARELA
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received04/06/2012
Decision Date 07/03/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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