Cleared Traditional

MASADA Modular Spinal Fixation System

K243259 · Astura Medical · Orthopedic

Jan 2025

Decision

84d

Days

Class 2

Risk

About This 510(k) Submission

K243259 is an FDA 510(k) clearance for the MASADA Modular Spinal Fixation System, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Astura Medical (Irving, US). The FDA issued a Cleared decision on January 7, 2025, 84 days after receiving the submission on October 15, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K243259 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 15, 2024
Decision Date	January 07, 2025
Days to Decision	84 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.