Cleared Traditional

K131417 - FACET FIXX (FDA 510(k) Clearance)

K131417 · Nexxt Spine, LLC · Orthopedic device

Jul 2013

Decision

57d

Days

Risk

K131417 is an FDA 510(k) clearance for the FACET FIXX. This device is classified as 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 FDA review panel.

Submission Details

510(k) Number	K131417 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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