Cleared Traditional

K132126 - SPECTRUM SPINE FENESTRATED FACET SCREW ...

K132126 · Spectrum Spine, LLC · Orthopedic device
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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K132126

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.

MRW Device Classification - Class 0,

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

Regulatory Peers - MRW System, Facet Screw Spinal Device

All 58
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K132126.
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K123932 · X-Spine Systems, Inc. · May 2013