Cleared Special

K240086 - Ion 3D (FDA 510(k) Clearance)

K240086 · SurGenTec, LLC · Orthopedic device

Feb 2024

Decision

28d

Days

—

Risk

K240086 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 February 8, 2024, 28 days after receiving the submission on January 11, 2024.

This device falls under the Orthopedic FDA review panel.

Submission Details

510(k) Number	K240086 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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