Cleared Traditional

K183589 - PMT Facet Screw (FDA 510(k) Clearance)

K183589 · Providence Medical Technology, Inc. · Orthopedic device

Oct 2019

Decision

294d

Days

Risk

K183589 is an FDA 510(k) clearance for the PMT Facet Screw. This device is classified as a System, Facet Screw Spinal Device.

Submitted by Providence Medical Technology, Inc. (Pleasanton, US). The FDA issued a Cleared decision on October 11, 2019, 294 days after receiving the submission on December 21, 2018.

This device falls under the Orthopedic FDA review panel.

Submission Details

510(k) Number	K183589 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 21, 2018
Decision Date	October 11, 2019
Days to Decision	294 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF