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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 K162121
Device Name Siconus SI Joint Fixation System
Applicant
CAMBER SPINE TECHNOLOGIES
418 E. LANCASTER AVE
WAYNE,  PA  19087
Applicant Contact DAMIAN HEINZ
Correspondent
MCRA, LLC
1331 H ST NW, 12TH FL
Washington,  DC  20005
Correspondent Contact Justin Eggleton
Regulation Number888.3040
Classification Product Code
OUR  
Date Received08/01/2016
Decision Date 01/18/2017
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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