Medical Device Manufacturer · US , Pittsburgh , PA

Blue Belt Technologies, Inc. - FDA 510(k) Cleared Devices

22 submissions · 22 cleared · Since 2012

Recent clearances: REAL INTELLIGENCE™ CORI™, REAL INTELLIGENCE™ CORI™ XT (CORI XT), CORIOGRAPH Pre-Op Planning and Modeling Services

22
Total
22
Cleared
0
Denied

Blue Belt Technologies, Inc. has 22 FDA 510(k) cleared orthopedic devices. Based in Pittsburgh, US.

Latest FDA clearance: Mar 2026. Active since 2012.

Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Blue Belt Technologies, Inc.

22 devices
1-22 of 22
Cleared Mar 26, 2026
REAL INTELLIGENCE™ CORI™
K260601 · OLO
Orthopedic · 30d
Cleared Dec 05, 2025
REAL INTELLIGENCE™ CORI™ XT (CORI XT)
K252841 · OLO
Orthopedic · 88d
Cleared Jun 25, 2025
CORIOGRAPH Pre-Op Planning and Modeling Services
K250921 · PBF
Orthopedic · 90d
Cleared Nov 15, 2024
CORIOGRAPH Pre-Op Planning and Modeling Services
K242272
Orthopedic · 106d
Cleared Mar 18, 2024
Real Intelligence™ CORI™
K240139 · OLO
Orthopedic · 60d
Cleared Aug 01, 2023
REAL INTELLIGENCE™ CORI™
K231963 · OLO
Orthopedic · 29d
Cleared Aug 19, 2022
REAL INTELLIGENCE CORI
K221224 · OLO
Orthopedic · 113d
Cleared Jul 27, 2022
Real Intelligence Cori
K220958 · OLO
Orthopedic · 117d
Cleared Mar 29, 2022
REAL INTELLIGENCE CORI
K220255 · OLO
Orthopedic · 57d
Cleared Mar 11, 2022
RI.HIP MODELER
K212040 · LLZ
Radiology · 254d
Cleared Nov 03, 2021
REAL INTELLIGENCE CORI (CORI)
K212537 · OLO
Orthopedic · 83d
Cleared Jun 12, 2020
REAL INTELLIGENCE CORI (CORI)
K201022 · OLO
Orthopedic · 53d
Cleared Feb 14, 2020
Real Intelligence Cori
K193120 · OLO
Orthopedic · 94d
Cleared Jun 28, 2019
NAVIO
K191223 · OLO
Orthopedic · 52d
Cleared Apr 06, 2018
NAVIO™ Surgical System (NAVIO system)
K180271 · OLO
Orthopedic · 65d
Cleared May 02, 2017
NAVIO
K170360 · OLO
Orthopedic · 85d
Cleared May 19, 2016
Navio
K160537 · OLO
Orthopedic · 83d
Cleared Oct 20, 2015
Navio
K152574 · OLO
Orthopedic · 41d
Cleared Mar 20, 2015
Navio
K143668 · OLO
Orthopedic · 86d
Cleared Jul 02, 2014
NAVIO
K140596 · OLO
Orthopedic · 117d
Cleared May 31, 2013
STRIDE UNICONDYLAR KNEE
K123380 · HSX
Orthopedic · 211d
Cleared Nov 30, 2012
NAVIOPFS
K121936 · OLO
Orthopedic · 151d
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