K253093

Vital™ Spinal Fixation System

510(k) number
K253093
Device name
Vital™ Spinal Fixation System
Applicant
Highridge Medical, LLC CO · US
Product code
NKB — Thoracolumbosacral Pedicle Screw System
Decision date
2025-12-17
Date received
2025-09-23
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Orthopedic
510(k) Summary (official FDA PDF): K253093.pdf
Official FDA record: K253093
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.