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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 K140359
Device Name MAXIMIS SPINAL FIXATION SYSTEM
Applicant
VALOREM SURGICAL
111 Hill Road
Douglassville,  PA  19518
Applicant Contact PATRICK MOORE
Correspondent
VALOREM SURGICAL
111 Hill Road
Douglassville,  PA  19518
Correspondent Contact Donald W. Guthner
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received02/12/2014
Decision Date 01/07/2015
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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