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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K223350
Device Name Remi Robotic Navigation System
Applicant
Fusion Robotics, LLC
168 Centennial Pkwy., Unit 170
Louisville,  CO  80027
Applicant Contact Sarah Braun
Correspondent
Integrity Implants Inc. Dba Accelus
354 Hiatt Dr.
Palm Beach Gardens,  FL  33418
Correspondent Contact Sarah Braun
Regulation Number882.4560
Classification Product Code
OLO  
Date Received11/02/2022
Decision Date 03/13/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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