Cleared Traditional

K192744 - CORRIDOR Fixation System (FDA 510(k) Clearance)

K192744 · Globus Medical, Inc. · Orthopedic device

Dec 2019

Decision

77d

Days

—

Risk

K192744 is an FDA 510(k) clearance for the CORRIDOR Fixation System. This device is classified as a System, Facet Screw Spinal Device.

Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on December 16, 2019, 77 days after receiving the submission on September 30, 2019.

This device falls under the Orthopedic FDA review panel.

Submission Details

510(k) Number	K192744 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 30, 2019
Decision Date	December 16, 2019
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF