Cleared Traditional

K173198 - Facet Screw Fixation System (FDA 510(k) Clearance)

K173198 · U&I Corporation · Orthopedic device

Jan 2018

Decision

93d

Days

—

Risk

K173198 is an FDA 510(k) clearance for the Facet Screw Fixation System. This device is classified as a System, Facet Screw Spinal Device.

Submitted by U&I Corporation (Uijeongbu-Si, KR). The FDA issued a Cleared decision on January 3, 2018, 93 days after receiving the submission on October 2, 2017.

This device falls under the Orthopedic FDA review panel.

Submission Details

510(k) Number	K173198 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 02, 2017
Decision Date	January 03, 2018
Days to Decision	93 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF