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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 K143377
Device Name PedFuse Pedicle Screw System
Applicant
Spinefrontier, Inc.
500 Cummings Center, Suite 3500
Beverly,  MA  01915
Applicant Contact Manthan J Damani
Correspondent
Empirical Testing Corp
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Kenneth C Maxwell
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received11/25/2014
Decision Date 02/12/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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