Cleared Traditional

K132859 - INTEGRA FACET FIXATION SYSTEM (FDA 510(k) Clearance)

K132859 · Seaspine, Inc. · Orthopedic device

Nov 2013

Decision

67d

Days

—

Risk

K132859 is an FDA 510(k) clearance for the INTEGRA FACET FIXATION SYSTEM. This device is classified as a System, Facet Screw Spinal Device.

Submitted by Seaspine, Inc. (Vista, US). The FDA issued a Cleared decision on November 18, 2013, 67 days after receiving the submission on September 12, 2013.

This device falls under the Orthopedic FDA review panel.

Submission Details

510(k) Number	K132859 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 12, 2013
Decision Date	November 18, 2013
Days to Decision	67 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF