Cleared Traditional

Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)

K252597 · Alphatec Spine, Inc. · Orthopedic

Feb 2026

Decision

188d

Days

Class 2

Risk

About This 510(k) Submission

K252597 is an FDA 510(k) clearance for the Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation), a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Alphatec Spine, Inc. (Carlsbad, US). The FDA issued a Cleared decision on February 19, 2026, 188 days after receiving the submission on August 15, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K252597 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 15, 2025
Decision Date	February 19, 2026
Days to Decision	188 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.