Cleared Special

K113011 - SPARTAN S3 FACET SYSTEM (FDA 510(k) Clearance)

K113011 · Amendia, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
56d
Days
-
Risk

K113011 is an FDA 510(k) clearance for the SPARTAN S3 FACET SYSTEM. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Amendia, Inc. (Apple Valley, US). The FDA issued a Cleared decision on December 6, 2011 after a review of 56 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 Amendia, Inc. devices

Submission Details

510(k) Number K113011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2011
Decision Date December 06, 2011
Days to Decision 56 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 122d · This submission: 56d
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 75
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K113011.
DiversiVy™ Facet Screw System
K253432 · Vy Spine, LLC · Mar 2026
Ion-C
K251714 · SurGenTec, LLC · Jan 2026
FFX Facet Fixation System
K250679 · Sc Medica · Dec 2025
CORUS-LX Implant
K253190 · Providence Medical Technology, Inc. · Nov 2025
FFX Facet Fixation System
K252153 · Sc Medica · Oct 2025
CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant
K251885 · Providence Medical Technology, Inc. · Jul 2025