Cleared Traditional

K243865 - AERO MIS Facet Fusion System (FDA 510(k) Clearance)

K243865 · Aurora Spine · Orthopedic device

Mar 2025

Decision

97d

Days

Risk

K243865 is an FDA 510(k) clearance for the AERO MIS Facet Fusion System. This device is classified as a System, Facet Screw Spinal Device.

Submitted by Aurora Spine (Carlsbad, US). The FDA issued a Cleared decision on March 24, 2025, 97 days after receiving the submission on December 17, 2024.

This device falls under the Orthopedic FDA review panel.

Submission Details

510(k) Number	K243865 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 17, 2024
Decision Date	March 24, 2025
Days to Decision	97 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF