Cleared Traditional

Ion Facet Screw System

K211855 · SurGenTec, LLC · Orthopedic
Feb 2022
Decision
254d
Days
—
Risk

About This 510(k) Submission

K211855 is an FDA 510(k) clearance for the Ion Facet Screw System, 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 review panel.

Submission Details

510(k) Number K211855 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code MRW — System, Facet Screw Spinal Device
Device Class —