Cleared Special

K123218 - ILLICO FS FACET FIXATION SYSTEM

K123218 · Alphatec Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K123218

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.

MRW Device Classification - Class 0,

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

Regulatory Peers - MRW System, Facet Screw Spinal Device

All 74
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K123218.
KOMPREDA
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RESOLUTE FACET SCREW SYSTEM
K121551 · Neurostructures, LLC · Oct 2012
VENUS FACET SCREW SYSTEM
K120340 · Apollo Spine, Inc. · Oct 2012
Typhoon(TM) Facet Screw Fixation System
K121850 · Choicespine, LP · Sep 2012