Cleared Traditional

K251714 - Ion-C (FDA 510(k) Clearance)

K251714 · SurGenTec, LLC · Orthopedic device

Jan 2026

Decision

227d

Days

—

Risk

K251714 is an FDA 510(k) clearance for the Ion-C. This device is classified as a System, Facet Screw Spinal Device.

Submitted by SurGenTec, LLC (Boca Raton, US). The FDA issued a Cleared decision on January 16, 2026, 227 days after receiving the submission on June 3, 2025.

This device falls under the Orthopedic FDA review panel.

Submission Details

510(k) Number	K251714 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 03, 2025
Decision Date	January 16, 2026
Days to Decision	227 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF