Cleared Traditional

Ion-C

K251714 · SurGenTec, LLC · Orthopedic
Jan 2026
Decision
227d
Days
—
Risk

About This 510(k) Submission

K251714 is an FDA 510(k) clearance for the Ion-C, 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 review panel.

Submission Details

510(k) Number K251714 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code MRW — System, Facet Screw Spinal Device
Device Class —

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