Cleared Traditional

Virata Spinal Fixation System

K250908 · SeaSpine Orthopedics Corporation · Orthopedic
Jun 2025
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K250908 is an FDA 510(k) clearance for the Virata Spinal Fixation System, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by SeaSpine Orthopedics Corporation (Carlsbad, US). The FDA issued a Cleared decision on June 18, 2025, 84 days after receiving the submission on March 26, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K250908 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 2025
Decision Date June 18, 2025
Days to Decision 84 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code NKB — Thoracolumbosacral Pedicle Screw System
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.

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