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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sacroiliac Joint Fixation
510(k) Number K150017
Device Name SpineFrontier SIJFuse Sacroiliac Joint Fusion Device 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 Number888.3040
Classification Product Code
OUR  
Date Received01/05/2015
Decision Date 04/24/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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