Cleared Traditional

Real Intelligence? CORI?

K240139 · Blue Belt Technologies, Inc. · Orthopedic

Mar 2024

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K240139 is an FDA 510(k) clearance for the Real Intelligence? CORI?, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Blue Belt Technologies, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on March 18, 2024, 60 days after receiving the submission on January 18, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K240139 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 18, 2024
Decision Date	March 18, 2024
Days to Decision	60 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OLO — Orthopedic Stereotaxic Instrument
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.4560
Definition	Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.