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Blue Belt Technologies, Inc

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
21
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2135-2024Class IICORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeoMay 7, 2024
Z-0708-2024Class IICORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013SNovember 13, 2023
Z-0041-2024Class IIReal Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) PrSeptember 7, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K252841REAL INTELLIGENCE™ CORI™ XT (CORI XT)December 5, 2025
K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesJune 25, 2025
K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesNovember 15, 2024
K240139Real Intelligence™ CORI™March 18, 2024
K231963REAL INTELLIGENCE™ CORI™August 1, 2023
K221224REAL INTELLIGENCE CORIAugust 19, 2022
K220958Real Intelligence CoriJuly 27, 2022
K220255REAL INTELLIGENCE CORIMarch 29, 2022
K212040RI.HIP MODELERMarch 11, 2022
K212537REAL INTELLIGENCE CORI (CORI)November 3, 2021
K201022REAL INTELLIGENCE CORI (CORI)June 12, 2020
K193120Real Intelligence CoriFebruary 14, 2020
K191223NAVIOJune 28, 2019
K180271NAVIO™ Surgical System (NAVIO system)April 6, 2018
K170360NAVIOMay 2, 2017
K160537NavioMay 19, 2016
K152574NavioOctober 20, 2015
K143668NavioMarch 20, 2015
K140596NAVIOJuly 2, 2014
K123380STRIDE UNICONDYLAR KNEEMay 31, 2013