Cleared Traditional

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

K161210 · Medtronic Sofamor Danek · Orthopedic

Aug 2016

Decision

106d

Days

Class 2

Risk

About This 510(k) Submission

K161210 is an FDA 510(k) clearance for the 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, a Sacroiliac Joint Fixation (Class II — Special Controls, product code OUR), submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on August 12, 2016, 106 days after receiving the submission on April 28, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K161210 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 28, 2016
Decision Date	August 12, 2016
Days to Decision	106 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF