Cleared Special

K123218 - ILLICO FS FACET FIXATION SYSTEM (FDA 510(k) Clearance)

K123218 · Alphatec Spine, Inc. · Orthopedic device

Nov 2012

Decision

44d

Days

—

Risk

K123218 is an FDA 510(k) clearance for the ILLICO FS FACET FIXATION SYSTEM. This device is classified as a System, Facet Screw Spinal Device.

Submitted by Alphatec Spine, Inc. (Carlsbad, US). The FDA issued a Cleared decision on November 28, 2012, 44 days after receiving the submission on October 15, 2012.

This device falls under the Orthopedic FDA review panel.

Submission Details

510(k) Number	K123218 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 15, 2012
Decision Date	November 28, 2012
Days to Decision	44 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF