Cleared Traditional

REAL INTELLIGENCE CORI

K221224 · Blue Belt Technologies, Inc. · Orthopedic

Aug 2022

Decision

113d

Days

Class 2

Risk

About This 510(k) Submission

K221224 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. (Plymouth, US). The FDA issued a Cleared decision on August 19, 2022, 113 days after receiving the submission on April 28, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K221224 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 28, 2022
Decision Date	August 19, 2022
Days to Decision	113 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.