Cleared Traditional

K132126 - SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM (FDA 510(k) Clearance)

K132126 · Spectrum Spine, LLC · Orthopedic device

Oct 2013

Decision

110d

Days

Risk

K132126 is an FDA 510(k) clearance for the SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM. This device is classified as a System, Facet Screw Spinal Device.

Submitted by Spectrum Spine, LLC (Waxhaw, US). The FDA issued a Cleared decision on October 28, 2013, 110 days after receiving the submission on July 10, 2013.

This device falls under the Orthopedic FDA review panel.

Submission Details

510(k) Number	K132126 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 10, 2013
Decision Date	October 28, 2013
Days to Decision	110 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF