Cleared Special

REAL INTELLIGENCE? CORI?

K231963 · Blue Belt Technologies, Inc. · Orthopedic

Aug 2023

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K231963 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 August 1, 2023, 29 days after receiving the submission on July 3, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K231963 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 03, 2023
Decision Date	August 01, 2023
Days to Decision	29 days
Submission Type	Special
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.