Cleared Special

Ion 3D

K240086 · SurGenTec, LLC · Orthopedic
Feb 2024
Decision
28d
Days
—
Risk

About This 510(k) Submission

K240086 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 February 8, 2024, 28 days after receiving the submission on January 11, 2024. This device falls under the Orthopedic review panel.

Submission Details

510(k) Number K240086 FDA.gov
FDA Decision Cleared SESE
Date Received January 11, 2024
Decision Date February 08, 2024
Days to Decision 28 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

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