Cleared Traditional

CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays

K241893 · Medos International SARL · Orthopedic

Sep 2024

Decision

80d

Days

Class 2

Risk

About This 510(k) Submission

K241893 is an FDA 510(k) clearance for the CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Medos International SARL (Lelocle, CH). The FDA issued a Cleared decision on September 16, 2024, 80 days after receiving the submission on June 28, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K241893 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 28, 2024
Decision Date	September 16, 2024
Days to Decision	80 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.