Cleared Traditional

K132859 - INTEGRA FACET FIXATION SYSTEM

K132859 · Seaspine, Inc. · Orthopedic device
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Nov 2013
Decision
67d
Days
-
Risk

K132859 is an FDA 510(k) clearance for the INTEGRA FACET FIXATION SYSTEM. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Seaspine, Inc. (Vista, US). The FDA issued a Cleared decision on November 18, 2013 after a review of 67 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Seaspine, Inc. devices

FDA 510(k) Submission Details - K132859

510(k) Number K132859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2013
Decision Date November 18, 2013
Days to Decision 67 days
Submission Type Traditional
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
55d faster than avg
Panel avg: 122d · This submission: 67d
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 76
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K132859.
FacetBRIDGE System
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Facet-Link Stabilization Platform
K150223 · Facet-Link, Inc. · Apr 2015
Proficient (TM) Facet Screw Spine System
K142980 · Spine Wave, Inc. · Jan 2015
SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM
K132126 · Spectrum Spine, LLC · Oct 2013
FACET SCREW SYSTEM
K130863 · Spinal USA · Aug 2013
FACET FIXX
K131417 · Nexxt Spine, LLC · Jul 2013