Cleared Traditional

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

K020411 · Nuvasive, Inc. · Orthopedic device

Mar 2002

Decision

33d

Days

—

Risk

K020411 is an FDA 510(k) clearance for the NUVASIVE TRIAD FACET SCREW SYSTEM. This device is classified as a System, Facet Screw Spinal Device.

Submitted by Nuvasive, Inc. (San Diego, US). The FDA issued a Cleared decision on March 12, 2002, 33 days after receiving the submission on February 7, 2002.

This device falls under the Orthopedic FDA review panel.

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