Cleared Traditional

Spine Navigation System

K233725 · Medivis, Inc. · Orthopedic

Jul 2024

Decision

248d

Days

Class 2

Risk

About This 510(k) Submission

K233725 is an FDA 510(k) clearance for the Spine Navigation System, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Medivis, Inc. (New York, US). The FDA issued a Cleared decision on July 26, 2024, 248 days after receiving the submission on November 21, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K233725 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 21, 2023
Decision Date	July 26, 2024
Days to Decision	248 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.