K241416 - Ion 3D

K241416 is an FDA 510(k) clearance for the Ion 3D. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by SurGenTec, LLC (Boca Raton, US). The FDA issued a Cleared decision on June 17, 2024 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.