Cleared Traditional

SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM (K132126) - FDA 510(k) Clearance

K132126 · Spectrum Spine, LLC · Orthopedic device
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Oct 2013
Decision
110d
Days
-
Risk

K132126 is an FDA 510(k) clearance for the SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Spectrum Spine, LLC (Waxhaw, US). The FDA issued a Cleared decision on October 28, 2013 after a review of 110 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Spectrum Spine, LLC devices

Submission Details

510(k) Number K132126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2013
Decision Date October 28, 2013
Days to Decision 110 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 122d · This submission: 110d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

Regulatory Peers - MRW System, Facet Screw Spinal Device

All 32
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K132126.
PMT Facet Screw
K183589 · Providence Medical Technology, Inc. · Oct 2019
FaSet Fixation System
K180729 · Huvexel Co. , Ltd. · Jun 2018
Facet Screw Fixation System
K173198 · U&I Corporation · Jan 2018
GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5
K112097 · Exactech, Inc. · Nov 2011
ZYFUSE FACET FIXATION SYSTEM
K090952 · Globus Medical, Inc. · Jul 2009
CORRIDOR FIXATION SYSTEM
K083442 · Globus Medical, Inc. · Feb 2009