Remi Robotic Navigation System

Orthopedic Stereotaxic Instrument

Fusion Robotics, LLC

The following data is part of a premarket notification filed by Fusion Robotics, Llc with the FDA for Remi Robotic Navigation System.

Pre-market Notification Details

Device IDK223070
510k NumberK223070
Device Name:Remi Robotic Navigation System
ClassificationOrthopedic Stereotaxic Instrument
Applicant Fusion Robotics, LLC 168 Centennial Parkway, Unit 170 Louisville,  CO  80027
ContactSarah Braun
CorrespondentSarah Braun
Integrity Implants Inc. Dba Accelus 354 Hiatt Drive Palm Beach Gardens,  FL  33418
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-09-30
Decision Date2022-10-28

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