Cleared Traditional

K130863 - FACET SCREW SYSTEM (FDA 510(k) Clearance)

K130863 · Spinal USA · Orthopedic device

Aug 2013

Decision

134d

Days

—

Risk

K130863 is an FDA 510(k) clearance for the FACET SCREW SYSTEM. This device is classified as a System, Facet Screw Spinal Device.

Submitted by Spinal USA (Philedelphia, US). The FDA issued a Cleared decision on August 9, 2013, 134 days after receiving the submission on March 28, 2013.

This device falls under the Orthopedic FDA review panel.

Submission Details

510(k) Number	K130863 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 28, 2013
Decision Date	August 09, 2013
Days to Decision	134 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF