Cleared Special

Ion 3D

K243265 · SurGenTec, LLC · Orthopedic
Dec 2024
Decision
50d
Days
—
Risk

About This 510(k) Submission

K243265 is an FDA 510(k) clearance for the Ion 3D, a System, Facet Screw Spinal Device, submitted by SurGenTec, LLC (Boca Raton, US). The FDA issued a Cleared decision on December 4, 2024, 50 days after receiving the submission on October 15, 2024. This device falls under the Orthopedic review panel.

Submission Details

510(k) Number K243265 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 2024
Decision Date December 04, 2024
Days to Decision 50 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

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