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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 K161210
Device Name RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems
Applicant
Medtronic Sofamor Danek
1800 Pyramid Pl.
Memphis,  TN  38132
Applicant Contact Ankit K. Shah
Correspondent
Medtronic Sofamor Danek
1800 Pyramid Pl.
Memphis,  TN  38132
Correspondent Contact Ankit K. Shah
Regulation Number888.3040
Classification Product Code
OUR  
Subsequent Product Codes
HWE   OLO  
Date Received04/28/2016
Decision Date 08/12/2016
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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