Cleared Traditional

PMT Posterior Cervical Stabilization System (PCSS)

K241035 · Providence Medical Technology, Inc. · Orthopedic
Jun 2024
Decision
70d
Days
—
Risk

About This 510(k) Submission

K241035 is an FDA 510(k) clearance for the PMT Posterior Cervical Stabilization System (PCSS), a System, Facet Screw Spinal Device, submitted by Providence Medical Technology, Inc. (Pleasanton, US). The FDA issued a Cleared decision on June 25, 2024, 70 days after receiving the submission on April 16, 2024. This device falls under the Orthopedic review panel.

Submission Details

510(k) Number K241035 FDA.gov
FDA Decision Cleared SESE
Date Received April 16, 2024
Decision Date June 25, 2024
Days to Decision 70 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MRW — System, Facet Screw Spinal Device
Device Class —