Cleared Traditional

MediRod Pedicle Screw System

K242764 · Cmf Medicon Surgical, Inc. · Orthopedic

Nov 2024

Decision

61d

Days

Class 2

Risk

About This 510(k) Submission

K242764 is an FDA 510(k) clearance for the MediRod Pedicle Screw System, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Cmf Medicon Surgical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on November 13, 2024, 61 days after receiving the submission on September 13, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K242764 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 13, 2024
Decision Date	November 13, 2024
Days to Decision	61 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	NKB — Thoracolumbosacral Pedicle Screw System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3070
Definition	Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.