Cleared Traditional

K020411 - NUVASIVE TRIAD FACET SCREW SYSTEM (FDA 510(k) Clearance)

K020411 · Nuvasive, Inc. · Orthopedic device
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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

Submission Details

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
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 122d · This submission: 33d
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 75
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