Home / 510(k) Clearances / K220958

510(k) K220958

Real Intelligence Cori by Blue Belt Technologies, Inc. — Product Code OLO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2022
Date Received
April 1, 2022
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)
  • K220255 — REAL INTELLIGENCE CORI (March 29, 2022)
  • K212040 — RI.HIP MODELER (March 11, 2022)
  • K212537 — REAL INTELLIGENCE CORI (CORI) (November 3, 2021)
  • 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)