Cleared Traditional

Excella Navigation Instruments

K223511 · Innovasis, Inc. · Orthopedic

May 2023

Decision

161d

Days

Class 2

Risk

About This 510(k) Submission

K223511 is an FDA 510(k) clearance for the Excella 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 May 2, 2023, 161 days after receiving the submission on November 22, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K223511 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 22, 2022
Decision Date	May 02, 2023
Days to Decision	161 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.