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

Sacroiliac Joint Fixation

Medtronic Sofamor Danek

The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for 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.

Pre-market Notification Details

Device IDK161210
510k NumberK161210
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
ClassificationSacroiliac Joint Fixation
Applicant Medtronic Sofamor Danek 1800 Pyramid Place Memphis,  TN  38132
ContactAnkit K. Shah
CorrespondentAnkit K. Shah
Medtronic Sofamor Danek 1800 Pyramid Place Memphis,  TN  38132
Product CodeOUR  
Subsequent Product CodeHWE
Subsequent Product CodeOLO
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-04-28
Decision Date2016-08-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169628977 K161210 000
00643169628953 K161210 000
00643169628960 K161210 000
00643169572546 K161210 000
00643169571792 K161210 000
00643169571808 K161210 000
00643169571815 K161210 000
00643169571822 K161210 000
00643169571846 K161210 000
00643169571860 K161210 000
00643169572560 K161210 000
00643169572577 K161210 000
00643169572584 K161210 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.