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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 K151462
FOIA Releasable 510(k) K151462
Device Name SI-TECHNOLOGY® SI-DESIS® SCREWS
Applicant
Si-Technology, LLC
320 E. Vine Dr., Suite 217
Fort Collins,  CO  80524
Applicant Contact CHRIS DONNER
Correspondent
Secure BioMed Evaluations
7828 Hickory Flat Highway Suite 120
Woodstock,  GA  30188
Correspondent Contact LINDA BRADDON
Regulation Number888.3040
Classification Product Code
OUR  
Subsequent Product Code
HWC  
Date Received06/01/2015
Decision Date 08/12/2015
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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