Cleared Traditional

K020411 - NUVASIVE TRIAD FACET SCREW SYSTEM

K020411 · Nuvasive, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
33d
Days
-
Risk

K020411 is an FDA 510(k) clearance for the NUVASIVE TRIAD FACET SCREW SYSTEM. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Nuvasive, Inc. (San Diego, US). The FDA issued a Cleared decision on March 12, 2002 after a review of 33 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 Nuvasive, Inc. devices

FDA 510(k) Submission Details - K020411

510(k) Number K020411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2002
Decision Date March 12, 2002
Days to Decision 33 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
89d faster than avg
Panel avg: 122d · This submission: 33d
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 50
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K020411.
CORRIDOR FIXATION SYSTEM
K083442 · Globus Medical, Inc. · Feb 2009
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
MODIFICATION TO TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM
K013829 · Medtronic Sofamor Danek, Inc. · Dec 2001
DISCOVERY FACET SCREW FIXATION SYSTEM
K012773 · Depuyacromed · Nov 2001
TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM
K003928 · Medtronic Sofamor Danek, Inc. · Jan 2001