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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name orthosis, spondylolisthesis spinal fixation
510(k) Number K123164
Device Name SPINEFRONTIER PEDFUSE PEDICLE SCREW 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 Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received10/09/2012
Decision Date 02/15/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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