Cleared Traditional

Innovasis Navigation Instruments

K250182 · Innovasis, Inc. · Orthopedic

Mar 2025

Decision

61d

Days

Class 2

Risk

About This 510(k) Submission

K250182 is an FDA 510(k) clearance for the Innovasis Navigation Instruments, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Innovasis, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on March 24, 2025, 61 days after receiving the submission on January 22, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K250182 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 22, 2025
Decision Date	March 24, 2025
Days to Decision	61 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.