Cleared Traditional

Navigated Instruments

K252742 · Tyber Medical, LLC · Orthopedic

Oct 2025

Decision

61d

Days

Class 2

Risk

About This 510(k) Submission

K252742 is an FDA 510(k) clearance for the Navigated Instruments, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Tyber Medical, LLC (Bethlehem, US). The FDA issued a Cleared decision on October 28, 2025, 61 days after receiving the submission on August 28, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K252742 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 28, 2025
Decision Date	October 28, 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.