Cleared Traditional

FACET FIXX

K131417 · Nexxt Spine, LLC · Orthopedic
Jul 2013
Decision
57d
Days
—
Risk

About This 510(k) Submission

K131417 is an FDA 510(k) clearance for the FACET FIXX, a System, Facet Screw Spinal Device, submitted by Nexxt Spine, LLC (Chesterland, US). The FDA issued a Cleared decision on July 12, 2013, 57 days after receiving the submission on May 16, 2013. This device falls under the Orthopedic review panel.

Submission Details

510(k) Number K131417 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 2013
Decision Date July 12, 2013
Days to Decision 57 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MRW — System, Facet Screw Spinal Device
Device Class —