Cleared Traditional

K083442 - CORRIDOR FIXATION SYSTEM (FDA 510(k) Clearance)

K083442 · Globus Medical, Inc. · Orthopedic device

Feb 2009

Decision

78d

Days

—

Risk

K083442 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 February 6, 2009, 78 days after receiving the submission on November 20, 2008.

This device falls under the Orthopedic FDA review panel.

Submission Details

510(k) Number	K083442 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 20, 2008
Decision Date	February 06, 2009
Days to Decision	78 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF