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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name thoracolumbosacral pedicle screw system
510(k) Number K113361
Device Name SECURIS SPINAL FIXATION
Applicant
CUMTOM SPINE
1140 PARSIPPANY BLVD.
SUITE 201
PARSIPPANY,  NJ  07054
Applicant Contact DAVID BRUMFIELD
Correspondent
CUMTOM SPINE
1140 PARSIPPANY BLVD.
SUITE 201
PARSIPPANY,  NJ  07054
Correspondent Contact DAVID BRUMFIELD
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received11/14/2011
Decision Date 04/03/2012
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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