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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 K151818
Device Name SImmetry Sacroiliac Joint Fusion System
Applicant
Zyga Technology, Inc.
5600 Rowland Rd., Suite 200
Minnetonka,  MN  55343
Applicant Contact Diane Brinza
Correspondent
Zyga Technology, Inc.
5600 Rowland Rd., Suite 200
Minnetonka,  MN  55343
Correspondent Contact Diane Brinza
Regulation Number888.3040
Classification Product Code
OUR  
Date Received07/06/2015
Decision Date 08/05/2015
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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