Cleared Special

K241416 - Ion 3D
(FDA 510(k) Clearance)

K241416 · SurGenTec, LLC · Orthopedic

Jun 2024

Decision

31d

Days

—

Risk

K241416 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 June 17, 2024, 31 days after receiving the submission on May 17, 2024.

This device falls under the Orthopedic FDA review panel.

Submission Details

510(k) Number	K241416 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 17, 2024
Decision Date	June 17, 2024
Days to Decision	31 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF