Cleared Traditional

Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)

K251073 · Innovasis, Inc. · Orthopedic

Jul 2025

Decision

106d

Days

Class 2

Risk

About This 510(k) Submission

K251073 is an FDA 510(k) clearance for the Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E 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 July 23, 2025, 106 days after receiving the submission on April 8, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K251073 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 08, 2025
Decision Date	July 23, 2025
Days to Decision	106 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.