Cleared Traditional

K994308 - NUVASIVE TOWNLEY FACET SCREW (FDA 510(k) Clearance)

K994308 · Nuvasive, Inc. · Orthopedic device

Apr 2000

Decision

119d

Days

—

Risk

K994308 is an FDA 510(k) clearance for the NUVASIVE TOWNLEY FACET SCREW. 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 April 18, 2000, 119 days after receiving the submission on December 21, 1999.

This device falls under the Orthopedic FDA review panel.

Submission Details

510(k) Number	K994308 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 21, 1999
Decision Date	April 18, 2000
Days to Decision	119 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF