Cleared Traditional

K090952 - ZYFUSE FACET FIXATION SYSTEM (FDA 510(k) Clearance)

K090952 · Globus Medical, Inc. · Orthopedic device

Jul 2009

Decision

102d

Days

—

Risk

K090952 is an FDA 510(k) clearance for the ZYFUSE FACET 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 July 14, 2009, 102 days after receiving the submission on April 3, 2009.

This device falls under the Orthopedic FDA review panel.

Submission Details

510(k) Number	K090952 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 03, 2009
Decision Date	July 14, 2009
Days to Decision	102 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF