Cleared Traditional

K220951 - PMT Facet Fixation System (PMT FFS) (FDA 510(k) Clearance)

K220951 · Providence Medical Technology, Inc. · Orthopedic device

Dec 2022

Decision

252d

Days

Risk

K220951 is an FDA 510(k) clearance for the PMT Facet Fixation System (PMT FFS). 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 December 9, 2022, 252 days after receiving the submission on April 1, 2022.

This device falls under the Orthopedic FDA review panel.

Submission Details

510(k) Number	K220951 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 01, 2022
Decision Date	December 09, 2022
Days to Decision	252 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF