Cleared Traditional

K132859 - INTEGRA FACET FIXATION SYSTEM

K132859 · Seaspine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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

Regulatory Peers - MRW System, Facet Screw Spinal Device

All 50
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K132859.
FaSet Fixation System
K180729 · Huvexel Co. , Ltd. · Jun 2018
Facet Screw Fixation System
K173198 · U&I Corporation · Jan 2018
Proficient (TM) Facet Screw Spine System
K142980 · Spine Wave, Inc. · Jan 2015
ZYGAFIX SPINAL FACET SCREW SYSTEM
K123932 · X-Spine Systems, Inc. · May 2013
ILLICO FS FACET FIXATION SYSTEM
K123218 · Alphatec Spine, Inc. · Nov 2012
RAPTOR FACET FIXATION SYSTEM
K110170 · Alphatec Spine, Inc. · Nov 2011