510(k) K212537

REAL INTELLIGENCE CORI (CORI) by Blue Belt Technologies, Inc. — Product Code OLO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 3, 2021
Date Received: August 12, 2021
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Orthopedic Stereotaxic Instrument
Device Class: Class II
Regulation Number: 882.4560
Review Panel: OR
Submission Type

Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.

Other clearances by Blue Belt Technologies, Inc.

K252841 — REAL INTELLIGENCE CORI XT (CORI XT) (December 5, 2025)
K250921 — CORIOGRAPH Pre-Op Planning and Modeling Services (June 25, 2025)
K242272 — CORIOGRAPH Pre-Op Planning and Modeling Services (November 15, 2024)
K240139 — Real Intelligence CORI (March 18, 2024)
K231963 — REAL INTELLIGENCE CORI (August 1, 2023)
K221224 — REAL INTELLIGENCE CORI (August 19, 2022)
K220958 — Real Intelligence Cori (July 27, 2022)
K220255 — REAL INTELLIGENCE CORI (March 29, 2022)
K212040 — RI.HIP MODELER (March 11, 2022)
K201022 — REAL INTELLIGENCE CORI (CORI) (June 12, 2020)

Other clearances for product code OLO

K260010 — TMINI® Miniature Robotic System (March 3, 2026)
K260222 — Mako Total Knee Application (February 25, 2026)
K252989 — POINT Kinguide Agile Hybrid Navigation System; DRF Accessories Set (February 20, 2026)
K254148 — VERTICALE GPS Instruments (February 19, 2026)
K252597 — Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For U (February 19, 2026)
K253623 — Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Upda (February 19, 2026)
K253381 — Stealth AXiS Surgical System with Stealth AXiS Spine clinical application (February 12, 2026)
K252873 — Q Interbody Instruments (February 6, 2026)
K252058 — ROSA Knee System with UltraSound Imaging Platform (USIP) (February 6, 2026)
K252871 — Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite (February 6, 2026)