510(k) clearance

Virata Spinal Fixation System

FDA 510(k) source

510(k) number

K262731

Applicant

SeaSpine Orthopedics Corporation

Decision date

Oct 29, 2026

Date received

Jul 31, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

NKB

Device type

Thoracolumbosacral Pedicle Screw System

Device class

Class II

Regulation

21 CFR 888.3070

Advisory committee

Orthopedic

Statement or summary

Summary

Third party

N

Location

Carlsbad, CA, US