Cleared Traditional

K230840 - PMT Facet Fixation System

K230840 · Providence Medical Technology, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Dec 2023
Decision
267d
Days
-
Risk

K230840 is an FDA 510(k) clearance for the PMT Facet Fixation System, Lumbar (PMT FFS-LX). Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Providence Medical Technology, Inc. (Pleasanton, US). The FDA issued a Cleared decision on December 19, 2023 after a review of 267 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Providence Medical Technology, Inc. devices

FDA 510(k) Submission Details - K230840

510(k) Number K230840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2023
Decision Date December 19, 2023
Days to Decision 267 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 122d · This submission: 267d
Pathway characteristics
Predicate-based equivalence.

MRW Device Classification - Class 0,

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

Regulatory Peers - MRW System, Facet Screw Spinal Device

All 55
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K230840.
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K232468 · Sc Medica · May 2024
zLOCK Lumbar Facet Fixation System
K240085 · Zygofix , Ltd. · Apr 2024
Ion 3D
K240086 · SurGenTec, LLC · Feb 2024
FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System
K232877 · K&J Consulting Corporation · Dec 2023
PMT Expandable Cage (PMT EXP)
K230297 · Providence Medical Technology, Inc. · Aug 2023
PMT Facet Fixation System (PMT FFS)
K220951 · Providence Medical Technology, Inc. · Dec 2022