Cleared Traditional

K192744 - CORRIDOR Fixation System

K192744 · Globus Medical, Inc. · Orthopedic device
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Dec 2019
Decision
77d
Days
-
Risk

K192744 is an FDA 510(k) clearance for the CORRIDOR Fixation System. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on December 16, 2019 after a review of 77 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 Globus Medical, Inc. devices

Submission Details

510(k) Number K192744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2019
Decision Date December 16, 2019
Days to Decision 77 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
45d faster than avg
Panel avg: 122d · This submission: 77d
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 48
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K192744.
PMT Facet Fixation System (PMT FFS)
K220951 · Providence Medical Technology, Inc. · Dec 2022
FaSet Fixation System
K222515 · Dio Medical Corporation · Oct 2022
Ion Facet Screw System
K211855 · SurGenTec, LLC · Feb 2022
AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine System, BOWTI Anterior Buttress Staple Spinal System, DISCOVERY Screw System, EXPEDIUM Anterior Spine System, FRONTIER Anterior Scoliosis System, KANEDA Anterior Scoliosis System, KANEDA SR Anterior Spinal System, M-2 Anterior Plate System, MOUNTAINEER Laminoplasty System, PROFILE Anterior Thoracolumbar Plate System, UNIVERSITY PLATE Anterior System, VIPER F2 Facet Fixation System
K192281 · Medos International SARL · Nov 2019
PMT Facet Screw
K183589 · Providence Medical Technology, Inc. · Oct 2019
FaSet Fixation System
K180729 · Huvexel Co. , Ltd. · Jun 2018