Cleared Traditional

K101284 - FACET SCREW SYSTEM (FDA 510(k) Clearance)

K101284 · Nuvasive, Inc. · Orthopedic device

Jul 2010

Decision

69d

Days

—

Risk

K101284 is an FDA 510(k) clearance for the 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 July 15, 2010, 69 days after receiving the submission on May 7, 2010.

This device falls under the Orthopedic FDA review panel.

Submission Details

510(k) Number	K101284 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 07, 2010
Decision Date	July 15, 2010
Days to Decision	69 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF