Cleared Traditional

Salvo? Robotic Navigation Instruments

K243514 · Spine Wave, Inc. · Orthopedic

Apr 2025

Decision

141d

Days

Class 2

Risk

About This 510(k) Submission

K243514 is an FDA 510(k) clearance for the Salvo? Robotic Navigation Instruments, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Spine Wave, Inc. (Shelton, US). The FDA issued a Cleared decision on April 3, 2025, 141 days after receiving the submission on November 13, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K243514 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 13, 2024
Decision Date	April 03, 2025
Days to Decision	141 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.