Cleared Traditional

K052043 - 3.8MM CS FACET COMPRESSION DEVICE

K052043 · Triage Medical, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Oct 2005
Decision
81d
Days
-
Risk

K052043 is an FDA 510(k) clearance for the 3.8MM CS FACET COMPRESSION DEVICE. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Triage Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on October 17, 2005 after a review of 81 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 Triage Medical, Inc. devices

FDA 510(k) Submission Details - K052043

510(k) Number K052043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2005
Decision Date October 17, 2005
Days to Decision 81 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
41d faster than avg
Panel avg: 122d · This submission: 81d
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 61
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K052043.
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CHAMELEON FIXATION SYSTEM
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STRYKER SPINE OASYS BONE SCREW
K031657 · Howmedica Osteonics Corp. · Aug 2003
MODIFICATION TO TOWNLEY TRANSFACEPEDICULAR SCREW FIXATION SYSTEM
K021705 · Medtronic Sofamor Danek, Inc. · Jul 2002
NUVASIVE TRIAD FACET SCREW SYSTEM
K020411 · Nuvasive, Inc. · Mar 2002