Cleared Special

K243265 - Ion 3D (FDA 510(k) Clearance)

K243265 · SurGenTec, LLC · Orthopedic device

Dec 2024

Decision

50d

Days

—

Risk

K243265 is an FDA 510(k) clearance for the Ion 3D. 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 December 4, 2024, 50 days after receiving the submission on October 15, 2024.

This device falls under the Orthopedic FDA review panel.

Submission Details

510(k) Number	K243265 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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