Cleared Special

K123218 - ILLICO FS FACET FIXATION SYSTEM

K123218 · Alphatec Spine, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Nov 2012
Decision
44d
Days
-
Risk

K123218 is an FDA 510(k) clearance for the ILLICO FS FACET FIXATION SYSTEM. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Alphatec Spine, Inc. (Carlsbad, US). The FDA issued a Cleared decision on November 28, 2012 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Alphatec Spine, Inc. devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 122d · This submission: 44d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MRW System, Facet Screw Spinal Device
Device Class -

Regulatory Peers - MRW System, Facet Screw Spinal Device

All 49
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K123218.
Facet Screw Fixation System
K173198 · U&I Corporation · Jan 2018
Proficient (TM) Facet Screw Spine System
K142980 · Spine Wave, Inc. · Jan 2015
ZYGAFIX SPINAL FACET SCREW SYSTEM
K123932 · X-Spine Systems, Inc. · May 2013
RAPTOR FACET FIXATION SYSTEM
K110170 · Alphatec Spine, Inc. · Nov 2011
GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5
K112097 · Exactech, Inc. · Nov 2011
VIPER F2 FACET FIXATION SYSTEM
K101762 · Depuy Spine, Inc. · Nov 2010