Cleared Traditional

K230297 - PMT Expandable Cage (PMT EXP) (FDA 510(k) Clearance)

K230297 · Providence Medical Technology, Inc. · Orthopedic device

Aug 2023

Decision

190d

Days

Risk

K230297 is an FDA 510(k) clearance for the PMT Expandable Cage (PMT EXP). 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 August 11, 2023, 190 days after receiving the submission on February 2, 2023.

This device falls under the Orthopedic FDA review panel.

Submission Details

510(k) Number	K230297 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 02, 2023
Decision Date	August 11, 2023
Days to Decision	190 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF