Cleared Traditional

K211855 - Ion Facet Screw System (FDA 510(k) Clearance)

K211855 · SurGenTec, LLC · Orthopedic device

Feb 2022

Decision

254d

Days

—

Risk

K211855 is an FDA 510(k) clearance for the Ion Facet Screw System. 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 25, 2022, 254 days after receiving the submission on June 16, 2021.

This device falls under the Orthopedic FDA review panel.

Submission Details

510(k) Number	K211855 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 16, 2021
Decision Date	February 25, 2022
Days to Decision	254 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF