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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 K110512
Device Name SIMMETRY SACROILIAC JOINT FUSION SYSTEM
Applicant
Zyga Technology, Inc.
700 10th Ave. S.,
Suite 400
Minneapolis,  MN  55415
Applicant Contact Diane Brinza
Correspondent
Zyga Technology, Inc.
700 10th Ave. S.,
Suite 400
Minneapolis,  MN  55415
Correspondent Contact Diane Brinza
Regulation Number888.3040
Classification Product Code
OUR  
Date Received02/23/2011
Decision Date 03/23/2011
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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