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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 K102907
Device Name SIMMETRY SACROILIAC JOINT FUSION SYSTEM
Applicant
Zyga Technology, Inc.
700 10TH AVENUE SOUTH,
SUITE 400
MINNEAPOLIS,  MN  55415
Applicant Contact Diane Brinza
Correspondent
Zyga Technology, Inc.
700 10TH AVENUE SOUTH,
SUITE 400
MINNEAPOLIS,  MN  55415
Correspondent Contact Diane Brinza
Regulation Number888.3040
Classification Product Code
OUR  
Date Received10/01/2010
Decision Date 12/14/2010
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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