Cleared Traditional

K001323 - NUVASIVE PERCUTANEOUS TRANSFACET/INTRAPEDICULAR SCREW (FDA 510(k) Clearance)

K001323 · Nuvasive, Inc. · Orthopedic device

Jul 2000

Decision

90d

Days

—

Risk

K001323 is an FDA 510(k) clearance for the NUVASIVE PERCUTANEOUS TRANSFACET/INTRAPEDICULAR 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 July 25, 2000, 90 days after receiving the submission on April 26, 2000.

This device falls under the Orthopedic FDA review panel.

Submission Details

510(k) Number	K001323 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 26, 2000
Decision Date	July 25, 2000
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF